510(k) K252921
- Device
- Radial Jaw 4 Pulmonary Biopsy Forceps
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K252921
- Product code
- BWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-26
- Date received
- 2025-09-12
- Regulation
- 874.4680
- Classification name
- Forceps, Biopsy, Bronchoscope (Non-Rigid)
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Elena Hennessey
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3007738736
- 3004962788
- 3005099803
- 3007695959
- 1056129
- 3008252486
- 1061927
Source Documents#
Other 510(k) Records For Product Code BWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | Boston Scientific Corp | 2012-05-16 |
| K102336 | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | Boston Scientific Corporation | 2011-01-24 |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Ballard Medical Products | 2002-10-11 |
| K930419 | WILTEK BIOPSY FORCEPS | Wiltek Medical, Inc. | 1993-06-01 |
| K843282 | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC | Rush Hampton Industries | 1984-10-22 |