REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
FDA 510(k) clearance K033593 · decided 2003-11-20
Clearance details
- K-number
- K033593
- Device name
- REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
- Applicant
- Clearmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-13
- Decision date
- 2003-11-20
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- NLU
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bellevue, WA, 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 HOT BIOPSY FORCEPS (K050136) | Sterilmed, Inc. | 2005-07-20 |
| SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (K024011) | Surgical Instruments Service and Savings, Inc. | 2002-12-19 |
| VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800) | Vanguard Medical Concepts, Inc. | 2001-09-27 |
Recalls involving this device
No recalls on record reference this clearance.