REPROCESSED ENDOSCOPIC ELECTRODES
FDA 510(k) clearance K012685 · decided 2002-02-14
Clearance details
- K-number
- K012685
- Device name
- REPROCESSED ENDOSCOPIC ELECTRODES
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2002-02-14
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- NLW
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G and recall (Z-0573-2009) | Sterilmed Inc | 2009-01-13 |