ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
FDA 510(k) clearance K063245 · decided 2007-11-28
Clearance details
- K-number
- K063245
- Device name
- ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
- Applicant
- Bacterin International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-26
- Decision date
- 2007-11-28
- Days to decision
- 398 days
- Clearance type
- Traditional
- Product code
- OEI
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain* recall (Z-1680-2014) | Bacterin International, Inc. | 2014-06-02 |
| Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fl recall (Z-0936-2013) | Bacterin International, Inc. | 2013-03-11 |