Obstetrics/Gynecology

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Code	Device name	Class	21 CFR	510(k) (3y)
FHG	Bell, Circumcision	Class 2	21 CFR 884.4530	2
FHJ	Shield, Circumcision	Class 2	21 CFR 884.4530	2
HCY	Curette, Uterine	Class 1	21 CFR 884.4530	11
HCZ	Forceps, Surgical, Gynecological	Class 2	21 CFR 884.4530	24
HDA	Forceps, Obstetrical	Class 2	21 CFR 884.4400	10
HDB	Extractor, Vacuum, Fetal	Class 2	21 CFR 884.4340	30
HDC	Tenaculum, Uterine	Class 2	21 CFR 884.4530	20
HDD	Table, Obstetrical, Ac-Powered (And Accessories)	Class 2	21 CFR 884.4900	7
HDE	Hook, Fibroid, Gynecological	Class 1	21 CFR 884.4520
HDF	Speculum, Vaginal, Metal	Class 1	21 CFR 884.4520	11
HDG	Speculum, Vaginal, Metal, Fiberoptic	Class 1	21 CFR 884.4520	2
HDH	Needle, Cerclage, Gynecological	Class 1	21 CFR 884.4530
HDI	Hook, Destructive, Obstetrical	Class 2	21 CFR 884.4500
HDJ	Scissors, Umbilical	Class 1	21 CFR 884.4520	1
HDK	Scissors, Episiotomy	Class 1	21 CFR 884.4520
HDL	Retractor, Vaginal	Class 1	21 CFR 884.4520	2
HDM	Packer, Uterine	Class 1	21 CFR 884.4520
HDN	Dilator, Cervical, Expandable	Class 3	21 CFR 884.4250
HDO	Valve, Tubal Occlusion	Class 3	21 CFR 884.5380
HDP	Elevator, Uterine	Class 2	21 CFR 884.4530	4
HDQ	Dilator, Cervical, Fixed Size	Class 1	21 CFR 884.4530	6
HDR	Cap, Cervical	Class 2	21 CFR 884.5250	29
HDT	Device, Intrauterine, Contraceptive And Introducer	Class 3	21 CFR 884.5360
HDW	Diaphragm, Contraceptive (And Accessories)	Class 2	21 CFR 884.5350	4
HDX	Dilator, Vaginal	Class 2	21 CFR 884.3900	9
HDY	Dilator, Cervical, Hygroscopic-Laminaria	Class 2	21 CFR 884.4260	11
HDZ	Knife, Cervical Cone	Class 2	21 CFR 884.4530
HEB	Tampon, Menstrual, Unscented	Class 2	21 CFR 884.5470	189
HEC	Insufflator, Vaginal	Class 1	21 CFR 884.5920
HED	Douche Apparatus, Vaginal, Therapeutic	Class 1	21 CFR 884.5900	12
HEE	Set, Anesthesia, Paracervical	Class 2	21 CFR 884.5100	9
HEG	Set, Anesthesia, Pudendal	Class 2	21 CFR 884.5100
HEH	Chamber, Decompression, Abdominal	Class 3	21 CFR 884.5225
HEI	Monitor, Heart-Valve Movement, Fetal, Ultrasonic	Class 2	21 CFR 884.2660	3
HEJ	Monitor, Hemic Sound, Ultrasonic	Class 2	21 CFR 884.2660
HEK	Monitor, Heart Sound, Fetal, Ultrasonic	Class 2	21 CFR 884.2660	5
HEL	Monitor, Heart Rate, Fetal, Ultrasonic	Class 2	21 CFR 884.2660	7
HEM	Imager, Ultrasonic Obstetric-Gynecologic	Class 2	21 CFR 884.2225	30
HEN	Caliper, Fetal Head, Ultrasonic	Class 2	21 CFR 884.2225
HEO	Analyzer, Data, Obstetric	Class 3	21 CFR 884.2050
HEP	Monitor, Blood-Flow, Ultrasonic	Class 2	21 CFR 884.2660	4
HEQ	Monitor, Pressure, Arterial, Fetal, Ultrasonic	Class 2	21 CFR 884.2660
HER	Pelvimeter, External	Class 1	21 CFR 884.4520
HES	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)	Class 2	21 CFR 884.1300	13
HET	Laparoscope, Gynecologic (And Accessories)	Class 2	21 CFR 884.1720	338
HEW	Culdoscope (And Accessories)	Class 2	21 CFR 884.1640	18
HEX	Colposcope (And Colpomicroscope)	Class 2	21 CFR 884.1630	56
HEZ	Endoscope, Transcervical (Amnioscope)(And Accessories)	Class 2	21 CFR 884.1660
HFA	Amnioscope, Transabdominal (Fetoscope) (And Accessories)	Class F	21 CFR 884.1600
HFB	Forceps, Biopsy, Gynecological	Class 1	21 CFR 884.4530	22
HFC	Aspirator, Endocervical	Class 2	21 CFR 884.1050	11
HFD	Washer, Endometrial	Class 2	21 CFR 884.1185	3
HFE	Brush, Endometrial	Class 2	21 CFR 884.1100	9
HFF	Aspirator, Endometrial	Class 2	21 CFR 884.1060	5
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Class 2	21 CFR 884.4160	11
HFH	Coagulator, Hysteroscopic (And Accessories)	Class 2	21 CFR 884.4160
HFI	Coagulator, Culdoscopic (And Accessories)	Class 2	21 CFR 884.4160	8
HFJ	Prosthesis, Fallopian Tube	Class 2	21 CFR 884.3650	1
HFK	Mold, Vaginal	Class 2	21 CFR 884.3900	1
HFL	Drain, Cervical	Class 2	21 CFR 884.3200	1
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Class 2	21 CFR 884.2720	23
HFN	Transducer, Pressure, Intrauterine	Class 2	21 CFR 884.2700	9
HFO	Recorder, Pressure, Intrauterine	Class 2	21 CFR 884.2700	4
HFP	Monitor, Phonocardiographic, Fetal	Class 2	21 CFR 884.2640
HFW	Clamp, Umbilical	Class 2	21 CFR 884.4530	36
HFX	Clamp, Circumcision	Class 2	21 CFR 884.4530	27
HFY	Band, Tubal Occlusion	Class 3	21 CFR 884.5380
HFZ	Craniotribe	Class 2	21 CFR 884.4500
HGA	Cranioclast	Class 2	21 CFR 884.4500
HGB	Clip, Tubal Occlusion	Class 3	21 CFR 884.5380
HGC	Clamp, Uterine	Class 1	21 CFR 884.4520	2
HGD	Applicator, Vaginal	Class 1	21 CFR 884.4520	1
HGE	Amniotome	Class 1	21 CFR 884.4530	6
HGF	Source, Abortion Unit, Vacuum	Class 2	21 CFR 884.5070	4
HGG	Controller, Abortion Unit, Vacuum	Class 2	21 CFR 884.5070	1
HGH	Cannula, Suction, Uterine	Class 2	21 CFR 884.5070	6
HGI	Electrocautery, Gynecologic (And Accessories)	Class 2	21 CFR 884.4120	53
HGK	Endoscope, Fetal Blood Sampling (And Accessories)	Class 2	21 CFR 884.1660	1
HGL	Transducer, Ultrasonic, Obstetric	Class 2	21 CFR 884.2960	36
HGM	System, Monitoring, Perinatal	Class 2	21 CFR 884.2740	215
HGN	Stethoscope, Fetal	Class 1	21 CFR 884.2900	2
HGO	Monitor, Electroencephalographic, Fetal (And Accessories)	Class 3	21 CFR 884.2620
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Class 2	21 CFR 884.2675	17
HGS	Catheter, Intrauterine And Introducer	Class 2	21 CFR 884.2700	2
HGW	Sampler, Blood, Fetal	Class 2	21 CFR 884.1560	4
HGX	Pump, Breast, Powered	Class 2	21 CFR 884.5160	250
HGY	Pump, Breast, Non-Powered	Class 1	21 CFR 884.5150	27
HGZ	Heater, Perineal, Direct Contact	Class 2	21 CFR 884.5390	1
HHA	Heater, Perineal, Radiant, Non-Contact	Class 2	21 CFR 884.5390
HHD	Pad, Menstrual, Unscented	Class 1	21 CFR 884.5435	136
HHE	Cup, Menstrual	Class 2	21 CFR 884.5400	16
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Class 1	21 CFR 884.4530	6
HHG	Dilator, Cervical, Vibratory	Class 3	21 CFR 884.4270
HHI	System, Abortion, Vacuum	Class 2	21 CFR 884.5070	24
HHJ	Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic	Class 2	21 CFR 884.2225	1
HHK	Curette, Suction, Endometrial (And Accessories)	Class 2	21 CFR 884.1175	42
HHL	Pad, Menstrual, Scented, Scented-Deodorized	Class 2	21 CFR 884.5425	57
HHM	Sound, Uterine	Class 1	21 CFR 884.4530	10
HHN	Cleidoclast	Class 2	21 CFR 884.4500
HHO	Screw, Fibroid, Gynecological	Class 2	21 CFR 884.4530	2
HHP	Table, Obstetrical, Manual (And Accessories)	Class 2	21 CFR 884.4900	2
HHQ	System, Abortion, Metreurynter-Balloon	Class 3	21 CFR 884.5050
HHR	Laser, Surgical, Gynecologic	Class 2	21 CFR 884.4550	48
HHS	Transcervical Contraceptive Tubal Occlusion Device	Class 3	21 CFR 884.5380
HHT	Spatula, Cervical, Cytological	Class 2	21 CFR 884.4530	73
HHW	Pessary, Vaginal	Class 2	21 CFR 884.3575	41
HHX	Holograph, Fetal, Acoustical	Class 2	21 CFR 884.2225
HIB	Speculum, Vaginal, Nonmetal	Class 2	21 CFR 884.4530	72
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic	Class 2	21 CFR 884.4530	5
HIF	Insufflator, Laparoscopic	Class 2	21 CFR 884.1730	179
HIG	Insufflator, Hysteroscopic	Class 2	21 CFR 884.1700	57
HIH	Hysteroscope (And Accessories)	Class 2	21 CFR 884.1690	172
HII	Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use	Class 3	21 CFR 884.5940
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Class 2	21 CFR 884.5460	84
HIM	Electrocautery, Endoscopic And Accessories	Class 2	21 CFR 884.4100
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Class 2	21 CFR 884.4150	16
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Class 1	21 CFR 884.1550	20
HIQ	Electrode, Clip, Fetal Scalp (And Applicator)	Class 3	21 CFR 884.2685
HIR	Perineometer	Class 2	21 CFR 884.1425	65
HIS	Condom	Class 2	21 CFR 884.5300	401
IYM	System, Telethermographic, Infrared	Class 3	21 CFR 884.2980	8
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Class 2	21 CFR 884.4530	58
KNB	Instrument, Destructive, Fetal, Obstetric	Class 2	21 CFR 884.4500	1
KNC	Table, Obstetric (And Accessories)	Class 2	21 CFR 884.4900	26
KND	Heater, Perineal	Class 2	21 CFR 884.5390
KNE	Set, Anesthesia, Obstetric	Class 2	21 CFR 884.5100	2
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Class 2	21 CFR 884.4160	44
KNG	Monitor, Ultrasonic, Fetal	Class 2	21 CFR 884.2660	60
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Class 3	21 CFR 884.5380
KOH	Instrument, Manual, General Obstetric-Gynecologic	Class 1	21 CFR 884.4520	15
KXN	Monitor, Cardiac, Fetal	Class 2	21 CFR 884.2600	2
KXO	Monitor, Pressure, Intrauterine	Class 2	21 CFR 884.2700	26
KXP	Stent, Vaginal	Class 2	21 CFR 884.3900	4
KXQ	Vibrator For Therapeutic Use, Genital	Class 2	21 CFR 884.5960	4
KXZ	System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)	Class 3	21 CFR 884.2982	7
KYA	System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)	Class 1	21 CFR 884.2982	5
LBX	Pelvimeter, Internal	Class 2	21 CFR 884.4530	1
LHM	System, Thermographic, Liquid Crystal	Class 1	21 CFR 884.2982	1
LHP	System, Telethermographic (Sole Diagnostic Screen)	Class 3	21 CFR 884.2980
LHQ	System, Telethermographic (Adjunctive Use)	Class 1	21 CFR 884.2980	41
LHR	System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)	Class 3	21 CFR 884.2982
LHZ	Viscometer, Mucus, Cervical	Class 1	21 CFR 884.1040	1
LKF	Cannula, Manipulator/Injector, Uterine	Class 2	21 CFR 884.4530	87
LLW	Laser, Neodymium:Yag For Gynecologic Use	Class 2	21 CFR 884.4550	1
LQK	Home Uterine Activity Monitor	Class 2	21 CFR 884.2730	5
LTZ	Condom With Nonoxynol-9	Class 2	21 CFR 884.5310	22
LXE	Doppler, Fetal, Ultrasound	Class 2	21 CFR 884.2660
LZL	Micro-Condom	Class 3	21 CFR 884.5320
MAA	Monitor, Fetal Doppler Ultrasound	Class 2	21 CFR 884.2660	9
MBU	Single-Use Internal Condom	Class 2	21 CFR 884.5340
MDG	System, Intrafallopian Cannula	Class 2	21 CFR 884.4530	1
MFD	Cannula, Intrauterine Insemination	Class 2	21 CFR 884.5250	29
MKO	Falloposcope	Class 2	21 CFR 884.1690	4
MLS	Labor And Delivery Kit	Class 2	21 CFR 884.4530	6
MLT	Pelvic Exam Kit	Class 2	21 CFR 884.4530	1
MOH	Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)	Class 2	21 CFR 884.2730
MOK	Vaginoscope And Accessories	Class 2	21 CFR 884.1630	2
MOL	Condom, Synthetic	Class 2	21 CFR 884.5300	23
MOV	Catheters, Salpingography	Class 2	21 CFR 884.4530	5
MPT	Contraception Calculator	Class 2	21 CFR 884.5350	1
MPU	Source, Chemiluminescent Light	Class 2	21 CFR 884.4530	2
MQE	Needle, Assisted Reproduction	Class 2	21 CFR 884.6100	33
MQF	Catheter, Assisted Reproduction	Class 2	21 CFR 884.6110	53
MQG	Accessory, Assisted Reproduction	Class 2	21 CFR 884.6120	47
MQH	Microtools, Assisted Reproduction (Pipettes)	Class 2	21 CFR 884.6130	26
MQI	Microtool Fabrication, Assisted Reproduction	Class 2	21 CFR 884.6140
MQJ	Micromanipulators And Microinjectors, Assisted Reproduction	Class 2	21 CFR 884.6150	23
MQK	Labware, Assisted Reproduction	Class 2	21 CFR 884.6160	50
MQL	Media, Reproductive	Class 2	21 CFR 884.6180	260
MRX	System, Assisted Reproduction Laser	Class 2	21 CFR 884.6200	11
MSC	Barrier, Std, Oral Sex	Class 2	21 CFR 884.5300	7
MTW	System, Water, Reproduction, Assisted, And Purification	Class 2	21 CFR 884.6170	2
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Class 1	21 CFR 884.6190
NBV	Device, Engorgement, Clitoral	Class 2	21 CFR 884.5970	3
NBZ	Clamp And Cutter, Umbilical	Class 2	21 CFR 884.4530	1
NHM	Sheet, Recording, Breast Examination	Class 2	21 CFR 884.2990	2
NKA	System, Documentation, Breast Lesion	Class 2	21 CFR 884.2990	4
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Class 1	21 CFR 884.1730
NMG	Forceps, Biopsy, Gynecological, Reprocessed	Class 2	21 CFR 884.4530
NMH	Laparoscope And Accessories, Gynecologic, Reprocessed	Class 2	21 CFR 884.1720
NMI	Laparoscopic Insufflator And Accessories, Reprocessed	Class 1	21 CFR 884.1730
NNB	Needle, Reproduction, Assisted, Reprocessed	Class 2	21 CFR 884.6100
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic	Class 1	21 CFR 884.5425
NUC	Lubricant, Personal	Class 2	21 CFR 884.5300	247
NUQ	Pad, Menstrual, Reusable	Class 1	21 CFR 884.5435	1
NUR	Pad, Menstrual, Intralabial	Class 1	21 CFR 884.5435
NVT	Tubing And Tubing/Filter Fits	Class 1	21 CFR 884.1700
NWV	Laparoscopic Accessories, Gynecologic	Class 1	21 CFR 884.1720
NWW	Hysteroscope Accessories	Class 1	21 CFR 884.1690
OBB	Kit, Conception-Assist, Home Use	Class 2	21 CFR 884.5250	4
OBY	Condom, Female, Animal Tissue	Class 3	21 CFR 884.5330
OCQ	Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incont	Class 2	21 CFR 884.1720
OHC	Obstetrical Vacuum Delivery Kit	Class 2	21 CFR 884.4340
OHD	Gynecological Laparoscopic Kit	Class 2	21 CFR 884.1720
OHE	Forensic Evidence Sexual Assault Kit	Class 2	21 CFR 884.1630
OHF	Culdocentesis Kit	Class 2	21 CFR 884.1640
OHG	Circumcision Tray	Class 2	21 CFR 884.4530
OHH	Breast Pump Kit	Class 2	21 CFR 884.5160
OHL	Pap Smear Kit	Class 2	21 CFR 884.4530
OHM	Cesarean Section Tray	Class 2	21 CFR 884.1720