Obstetrics/Gynecology

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Code	Device name	Class	21 CFR	510(k) (3y)
OJF	Hysterectomy Kit	Class 2	21 CFR 884.4530
OKU	Emergency Obstetrical Kit	Class 1	21 CFR 884.4520
OKV	Obstetrical Kit	Class 2	21 CFR 884.4520
OKW	Seminal Fluid Collection Kit	Class 2	21 CFR 884.5300
OKX	Trocar Kit	Class 2	21 CFR 884.1720
OKY	Cytology Kit	Class 2	21 CFR 884.4530
OKZ	Endometrial Sampling Kit	Class 2	21 CFR 884.1175
ONX	Ovarian Adnexal Mass Assessment Score Test System	Class 2	21 CFR 866.6050	6
OOA	Hemorrhoid Prevention Pressure Wedge	Class 2	21 CFR 884.5200	1
OQY	Intrauterine Tamponade Balloon	Class 2	21 CFR 884.4530	11
OSP	Uterine Electromyographic Monitor	Class 2	21 CFR 884.2720	10
OSV	Insufflator, Endoscopic Vessel Harvesting	Class 2	21 CFR 884.1730
OTP	Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse,	Class 3	21 CFR 884.5980	31
OYO	Culture, Intravaginal, Assisted Reproduction	Class 2	21 CFR 884.6165	2
PAI	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolap	Class 3	21 CFR 884.5980	2
PBH	Embryo Image Assessment System, Assisted Reproduction	Class 2	21 CFR 884.6195	5
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Class 2	21 CFR 884.4530	8
PCF	Sampler, Endocervical	Class 2	21 CFR 884.1050	5
PEB	Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	Class 2	21 CFR 884.5300	10
PFJ	Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor	Class 2	21 CFR 884.4260	2
PGK	Cannula, Injector, Uterine, Endometrial Biopsy	Class 2	21 CFR 884.4530	2
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutt	Class 2	21 CFR 884.1710	3
PKN	Dilator, Cervical, Synthetic, Osmotic	Class 2	21 CFR 884.4260	1
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument P	Class 2	21 CFR 884.4050	4
PNU	Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery	Class 2	21 CFR 884.5210	1
PON	Catheter, Balloon, Dilation Of Cervical Canal	Class 2	21 CFR 884.4260	4
PTE	Endoscopic Morcellator Gastroenterology	Class 2	21 CFR 884.1690	2
PTZ	Colposcope (And Colpomicroscope), Exempt	Class 2	21 CFR 884.1630
PUA	Tenaculum, Uterine, Exempt	Class 2	21 CFR 884.4530
PUB	Accessory, Assisted Reproduction, Exempt	Class 2	21 CFR 884.6120	1
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Class 2	21 CFR 884.6130
PUD	Labware, Assisted Reproduction, Exempt	Class 2	21 CFR 884.6160
PVR	D&C Tray	Class 2	21 CFR 884.4530
PVS	Fetal Blood Sampling Kit (Excludes Hiv Testing)	Class 2	21 CFR 884.1560
PVT	Maternity Kit	Class 1	21 CFR 884.5435
PVU	Obstetrical Anesthesia Kit	Class 2	21 CFR 884.5100
PVV	Paracervical Anesthesia Kit	Class 2	21 CFR 884.5100
PVW	Pudendal Anesthesia Kit	Class 2	21 CFR 884.5100
PVX	Vaginal Examination Tray	Class 2	21 CFR 884.4530
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Class 1	21 CFR 884.5150
PWB	Fetal Head Elevator	Class 2	21 CFR 884.4350	2
PWI	Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of	Class 2	21 CFR 884.4910	2
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Inconti	Class 2	21 CFR 884.4910	5
PWK	Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair	Class 2	21 CFR 884.4910	1
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Class 2	21 CFR 884.5370	7
QAG	Endoscopic Electrosurgical Clip Cutting System	Class 2	21 CFR 876.4310	1
QFT	Digital Therapeutic Software For Attention Deficit Hyperactivity Disor	Class 2	21 CFR 882.5803	4
QHZ	Seal, Cervical, Mechanical, Unpowered	Class 1	21 CFR 884.1690
QKH	Assisted Reproduction Laminar Flow Workstation	Class 2	21 CFR 884.6120
QKI	Media, Reproductive, Exempt	Class 2	21 CFR 884.6180
QPD	Personal Lubricant Ring	Class 2	21 CFR 884.5300	1
QQR	Circumcision Device With Stapler	Class 2	21 CFR 884.4530
QRZ	External Condom For Anal Intercourse Or Vaginal Intercourse	Class 2	21 CFR 884.5305	1
QUJ	Automated Cryopreservation Storage System	Class 2	21 CFR 884.6120	1
QYZ	At Home Intravaginal Insemination System	Class 2	21 CFR 884.6110	3
SIM	Gynecologic Power Morcellator And Containment System	Class 2	21 CFR 884.4075	1