SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
FDA 510(k) clearance K024011 · decided 2002-12-19
Clearance details
- K-number
- K024011
- Device name
- SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-04
- Decision date
- 2002-12-19
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- NLU
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sisters, OR, US
- Third-party review
- Yes
- 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 HOT BIOPSY FORCEPS (K050136) | Sterilmed, Inc. | 2005-07-20 |
| REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (K033593) | Clearmedical, Inc. | 2003-11-20 |
| VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800) | Vanguard Medical Concepts, Inc. | 2001-09-27 |
Recalls involving this device
No recalls on record reference this clearance.