BTG

Brush, Biopsy, Bronchoscope (Non-Rigid)

Product code
BTG
Device name
Brush, Biopsy, Bronchoscope (Non-Rigid)
Device class
Class 2
21 CFR
21 CFR 874.4680
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
6

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 (1)

Last three years. Most recent: 2025-06-12.

NumberDecision dateApplicantDevice name
K2512792025-06-12Olympus Medical Systems CorporationDisposable Cytology Brush BC-202D/203D Series summary
Official FDA classification page: BTG
Classification and pathway per current FDA publications. Data from openFDA (CC0).