BWH — Forceps, Biopsy, Bronchoscope (Non-Rigid) Class II
FDA product code BWH covers "Forceps, Biopsy, Bronchoscope (Non-Rigid)", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BWH
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252921 | boston scientific corporation | Radial Jaw 4 Pulmonary Biopsy Forceps | September 26, 2025 |
| K121186 | boston scientific | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | May 16, 2012 |
| K102336 | boston scientific corporation | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY | January 24, 2011 |
| K022398 | ballard medical products | REUSABLE BRONCHIAL BIOPSY FORCEPS | October 11, 2002 |
| K930419 | wiltek medical | WILTEK BIOPSY FORCEPS | June 1, 1993 |
| K843282 | rush hampton industries | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC | October 22, 1984 |