MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
FDA 510(k) clearance K042659 · decided 2005-02-14
Clearance details
- K-number
- K042659
- Device name
- MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
- Applicant
- Medisiss
- Decision
- Substantially Equivalent
- Date received
- 2004-09-28
- Decision date
- 2005-02-14
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- NON
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redmond, OR, 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 |
|---|---|---|
| REPROCESSED COLD BIOPSY FORCEPS (K042648) | Sterilmed, Inc. | 2005-07-20 |
| VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) | Vanguard Medical Concepts, Inc. | 2005-01-25 |
Recalls involving this device
No recalls on record reference this clearance.