Product code BTG— Ear, Nose, Throat

CYTOLOGY BRUSH

Classification name: Brush, Biopsy, Bronchoscope (Non-Rigid)
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Total cleared: 6
First cleared: 1978-09-07
Most recent: 2025-06-12

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).”
— U.S. Food and Drug Administration, device classification record for product code BTG under 21 CFR 874.4680, via openFDA

Market context for product code BTG

FDA has cleared 6 devices under product code BTG between 1978 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20251 clearance
20201 clearance
20191 clearance
20131 clearance
19821 clearance
19781 clearance

Top applicants under product code BTG

Olympus Medical Systems Corporation1 clearance
Olympus Medical Systems Corp.1 clearance
Mill-Rose Laboratory1 clearance
Hobbs Medical, Inc.1 clearance
Covidien, LLC1 clearance
CooperVision, Inc.1 clearance

Recent clearances under product code BTG

K251279 — Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation·2025-06-12
K182927 — Pulmonary Cytology BrushHobbs Medical, Inc.·2020-02-07
K190293 — Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.·2019-08-02
K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHCovidien, LLC·2013-11-06
K820771 — MICROBIOLOGY SPECIMEN BRUSHMill-Rose Laboratory·1982-05-03
K780872 — CYTOLOGY BRUSHCooperVision, Inc.·1978-09-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.