REPROCESSED GUIDEWIRES
FDA 510(k) clearance K012556 · decided 2002-04-29
Clearance details
- K-number
- K012556
- Device name
- REPROCESSED GUIDEWIRES
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-08
- Decision date
- 2002-04-29
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- NML
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be used recall (Z-0558-2009) | Sterilmed Inc | 2009-01-13 |