FDA product code BWH: Forceps, Biopsy, Bronchoscope (Non-Rigid)
BWH is the FDA product code for forceps, biopsy, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under BWH, 1 in the last five years, from 5 different applicants. The average 510(k) review took 78 days (median 72); 14 days on average over the last three years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Bronchoscope (Non-Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BWH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 14 |
Compare with all 510(k) review times · Search every BWH clearance
Top BWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corporation | 2 | 2025-09-26 |
| Boston Scientific Corp | 1 | 2012-05-16 |
| Ballard Medical Products | 1 | 2002-10-11 |
| Wiltek Medical, Inc. | 1 | 1993-06-01 |
| Rush Hampton Industries | 1 | 1984-10-22 |
Most recent BWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252921 | Boston Scientific Corporation | Radial Jaw 4 Pulmonary Biopsy Forceps | 2025-09-26 | 14 |
| K121186 | Boston Scientific Corp | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | 2012-05-16 | 28 |
| K102336 | Boston Scientific Corporation | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | 2011-01-24 | 159 |
| K022398 | Ballard Medical Products | REUSABLE BRONCHIAL BIOPSY FORCEPS | 2002-10-11 | 80 |
| K930419 | Wiltek Medical, Inc. | WILTEK BIOPSY FORCEPS | 1993-06-01 | 126 |
Recalls for BWH devices
openFDA lists no recalls for product code BWH.
Frequently asked questions
What is FDA product code BWH?
BWH is the FDA product code for forceps, biopsy, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is BWH?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code BWH?
Across 6 cleared submissions the average was 78 days from receipt to decision (median 72).
Which companies have the most BWH clearances?
Boston Scientific Corporation (2); Boston Scientific Corp (1); Ballard Medical Products (1); Wiltek Medical, Inc. (1); Rush Hampton Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BWH
- Run a recall and safety report across every BWH manufacturer
- Watch product code BWH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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