REPROCESSED HOT BIOPSY FORCEPS
FDA 510(k) clearance K050136 · decided 2005-07-20
Clearance details
- K-number
- K050136
- Device name
- REPROCESSED HOT BIOPSY FORCEPS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-21
- Decision date
- 2005-07-20
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- NLU
- Device class
- 2
- Regulation number
- 876.4300
- 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 |
|---|---|---|
| REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (K033593) | Clearmedical, Inc. | 2003-11-20 |
| 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
| Record | Firm | Date |
|---|---|---|
| Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 recall (Z-0560-2009) | Sterilmed Inc | 2009-01-13 |