BWH · Forceps, Biopsy, Bronchoscope (Non-Rigid)
Ear, Nose, Throat · 21 CFR 874.4680 · Class 2
Overview
| Product Code | BWH |
|---|---|
| Device Name | Forceps, Biopsy, Bronchoscope (Non-Rigid) |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | Sep 26, 2025 | SESE |
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | Boston Scientific Corp | May 16, 2012 | SESE |
| K102336 | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | Boston Scientific Corporation | Jan 24, 2011 | SESE |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Ballard Medical Products | Oct 11, 2002 | SESE |
| K930419 | WILTEK BIOPSY FORCEPS | Wiltek Medical, Inc. | Jun 1, 1993 | SESE |
| K843282 | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC | Rush Hampton Industries | Oct 22, 1984 | SESE |
Top Applicants
- Boston Scientific Corporation — 2 clearances
- Wiltek Medical, Inc. — 1 clearance
- Rush Hampton Industries — 1 clearance
- Boston Scientific Corp — 1 clearance
- Ballard Medical Products — 1 clearance
