REPROCESSED ELECTROSURGICAL ELECTRODE
FDA 510(k) clearance K012684 · decided 2002-01-18
Clearance details
- K-number
- K012684
- Device name
- REPROCESSED ELECTROSURGICAL ELECTRODE
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2002-01-18
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- JOS
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision cutti recall (Z-0552-2009) | Sterilmed Inc | 2009-01-13 |