CONMED SELECT ONE LAPAROSCOPY ELECTRODE
FDA 510(k) clearance K960808 · decided 1996-03-21
Clearance details
- K-number
- K960808
- Device name
- CONMED SELECT ONE LAPAROSCOPY ELECTRODE
- Applicant
- Conmedcorp
- Decision
- Substantially Equivalent
- Date received
- 1996-02-28
- Decision date
- 1996-03-21
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dayton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as follows: recall (Z-1412-04) | Conmed Corporation | 2004-08-28 |
| ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Ca recall (Z-1413-04) | Conmed Corporation | 2004-08-28 |
| ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158 recall (Z-1301-04) | Conmed Corporation | 2004-07-31 |