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FDA Product Code

FDA Product Code BTG — Clearance Directory

Device Class
Class II
Assigned Panel
Ear, Nose, Throat
21 CFR Citation
874.4680

510(k) Clearances — 6 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K251279 Disposable Cytology Brush BC-202D/203D Series Olympus Medical Systems Corporation 2025-06-12 Traditional PDF ↗
K182927 Pulmonary Cytology Brush Hobbs Medical, Inc. 2020-02-07 Traditional PDF ↗
K190293 Single Use Cytology Brush BC-205D Olympus Medical Systems Corp. 2019-08-02 Traditional PDF ↗
K130357 SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH Covidien, LLC 2013-11-06 Traditional PDF ↗
K820771 MICROBIOLOGY SPECIMEN BRUSH Mill-Rose Laboratory 1982-05-03 Traditional PDF ↗
K780872 CYTOLOGY BRUSH CooperVision, Inc. 1978-09-07 Traditional PDF ↗

Product code BTG · Class II · Ear, Nose, Throat. Data: openFDA.