REPROCESSED COLD BIOPSY FORCEPS
FDA 510(k) clearance K042648 · decided 2005-07-20
Clearance details
- K-number
- K042648
- Device name
- REPROCESSED COLD BIOPSY FORCEPS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-28
- Decision date
- 2005-07-20
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- NON
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- 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 |
|---|---|---|
| MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (K042659) | Medisiss | 2005-02-14 |
| VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) | Vanguard Medical Concepts, Inc. | 2005-01-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC153 recall (Z-0575-2009) | Sterilmed Inc | 2009-01-13 |