MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
FDA 510(k) clearance K911160 · decided 1991-05-02
Clearance details
- K-number
- K911160
- Device name
- MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
- Applicant
- Mentor O & O, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-15
- Decision date
- 1991-05-02
- Days to decision
- 48 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
- Norwell, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: recall (Z-1594-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |