MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k) clearance K091087 · decided 2009-04-22
Clearance details
- K-number
- K091087
- Device name
- MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
- Applicant
- Surgical Devices, Tyco Healthcare Group LP
- Decision
- Substantially Equivalent
- Date received
- 2009-04-15
- Decision date
- 2009-04-22
- Days to decision
- 7 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Surgical Devices
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P recall (Z-2919-2026) | Covidien, LP | 2026-08-07 |