JEL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Curette, Biopsy, Bronchoscope (Rigid)

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

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).

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.