SURGICAL CUTTER
FDA 510(k) clearance K955168 · decided 1996-01-22
Clearance details
- K-number
- K955168
- Device name
- SURGICAL CUTTER
- Applicant
- Promex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-13
- Decision date
- 1996-01-22
- Days to decision
- 70 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
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifical recall (Z-2767-2015) | Nico Corp. | 2015-09-15 |