KTI

Bronchoscope Accessory

Product code
KTI
Device name
Bronchoscope Accessory
Device class
Class 2
21 CFR
21 CFR 874.4680
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
510(k) clearances (last 3 years)
34

FDA classification definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (10)

Last three years. Most recent: 2026-07-24.

NumberDecision dateApplicantDevice name
K2612742026-07-24Cook Ireland, Ltd.EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Ne summary
K2514782026-04-16Finemedix Co., Ltd.ClearTip TBNA Type summary
K2540402026-03-12Free Flow Medical, Inc.LungFlow Basket Catheter summary
K2514022025-12-19Leadoptik, Inc.LIA-1 Catheter (542-1) summary
K2528742025-10-08Serpex Medical, Inc.Compass Steerable Needle with Adapters SRA-1-01 and summary
K2516642025-07-29Olympus Medical Systems CorporationSingle Use Aspiration Needle (NA-201SX-4021); Singl summary
K2502632025-03-31Olympus Medical Systems Corp.Disposable Grasping Forceps FG-52D/FG-54D summary
K2416792025-03-04Alton (Shanghai) Medical Instruments CDisposable Cytology Brush (AF series) summary
K2318182023-11-15M/S Meril Life Sciences Pvt. , Ltd.METIC™- Airway Balloon Catheter summary
K2307782023-09-25Praxis Medical, LLCEndoCore summary
Official FDA classification page: KTI
Classification and pathway per current FDA publications. Data from openFDA (CC0).