AESCULAP BIOPOLAR COAGULATOR
FDA 510(k) clearance K952524 · decided 1995-06-29
Clearance details
- K-number
- K952524
- Device name
- AESCULAP BIOPOLAR COAGULATOR
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-01
- Decision date
- 1995-06-29
- Days to decision
- 28 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
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is int recall (Z-0479-2014) | Aesculap, Inc. | 2013-12-11 |