BTGClass II

Brush, Biopsy, Bronchoscope (Non-Rigid)

21 CFR 874.4680 / Ear, Nose, Throat

BTG is the FDA product code for Brush, Biopsy, Bronchoscope (Non-Rigid), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 2025-06-12, and 2 recalls.

Classification record

Product code: BTG
Device name: Brush, Biopsy, Bronchoscope (Non-Rigid)
FDA 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).
Regulation: 21 CFR 874.4680
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 6
Ingested recalls: 2

Clearances, product code BTG

By decision year

6 clearances under product code BTG with a decision year between 1978 and 2025, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code BTG by decision year
Year	Clearances
1978	1
1982	1
2013	1
2019	1
2020	1
2025	1

Applicants with the most clearances

Product code BTG

Applicants holding the most 510(k) clearances under product code BTG
Applicant	Clearances
Olympus Medical Systems Corp.	2
CooperVision, Inc.	1
Medtronic, Inc.	1
Hobbs Medical, Inc.	1
Mill-Rose Laboratory	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order