ENSEAL PTC TRIO
FDA 510(k) clearance K070165 · decided 2007-01-29
Clearance details
- K-number
- K070165
- Device name
- ENSEAL PTC TRIO
- Applicant
- Surgrx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-18
- Decision date
- 2007-01-29
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05 recall (Z-2635-2010) | Ethicon Endo-Surgery Inc | 2010-09-30 |