RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
FDA 510(k) clearance K102336 · decided 2011-01-24
Clearance details
- K-number
- K102336
- Device name
- RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-08-18
- Decision date
- 2011-01-24
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- BWH
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- El Coyol,Alajuela, CR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Radial Jaw 4 Pulmonary Biopsy Forceps (K252921) | Boston Scientific Corporation | 2025-09-26 |
| RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (K121186) | Boston Scientific Corp | 2012-05-16 |
| REUSABLE BRONCHIAL BIOPSY FORCEPS (K022398) | Ballard Medical Products | 2002-10-11 |
| WILTEK BIOPSY FORCEPS (K930419) | Wiltek Medical, Inc. | 1993-06-01 |
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No recalls on record reference this clearance.
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