VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k) clearance K100257 · decided 2010-05-10
Clearance details
- K-number
- K100257
- Device name
- VLOC9ABSORBABLE WOUND CLOSURE DEVICE
- Applicant
- Surgical Devices, A Division of Tyco Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2010-01-28
- Decision date
- 2010-05-10
- Days to decision
- 102 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
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall (Z-2918-2026) | Covidien, LP | 2026-08-07 |