VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
FDA 510(k) clearance K946271 · decided 1995-06-15
Clearance details
- K-number
- K946271
- Device name
- VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-23
- Decision date
- 1995-06-15
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somervi recall (Z-1309-2009) | Ethicon, Inc. | 2009-05-12 |
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