Forceps, Biopsy, Bronchoscope (Non-Rigid)
FDA product code BWH · Class II (moderate risk) · 21 CFR 874.4680 · Ear, Nose, Throat
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).
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | Boston Scientific Corporation | 09/26/2025SE |
| K121186 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | Boston Scientific Corp | 05/16/2012SE |
| K102336 | Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard…BWH · Traditional | Boston Scientific Corporation | 01/24/2011SE |
| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | Ballard Medical Products | 10/11/2002SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | Wiltek Medical, Inc. | 06/01/1993SE |
| K843282 | Universal by Rush-Hampton ArthroscopicBWH · Traditional | Rush Hampton Industries | 10/22/1984SE |