UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
FDA 510(k) clearance K970066 · decided 1997-02-18
Clearance details
- K-number
- K970066
- Device name
- UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
- Applicant
- Unimed Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-08
- Decision date
- 1997-02-18
- Days to decision
- 41 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
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutti recall (Z-1347-2013) | Unimed Surgical Products, Inc. | 2013-05-22 |