Product code BWH— Ear, Nose, Throat
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
- Classification name
- Forceps, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 6
- First cleared
- Most recent
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).”
Market context for product code BWH
FDA has cleared devices under product code BWH between 1984 and 2025, filed by 5 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
- 2025
- 2012
- 2011
- 2002
- 1993
- 1984
Top applicants under product code BWH
Recent clearances under product code BWH
- K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps
- K121186 — RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
- K102336 — RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
- K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS
- K930419 — WILTEK BIOPSY FORCEPS
- K843282 — UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.