V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
FDA 510(k) clearance K111442 · decided 2011-06-03
Clearance details
- K-number
- K111442
- Device name
- V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
- Decision
- Substantially Equivalent
- Date received
- 2011-05-24
- Decision date
- 2011-06-03
- Days to decision
- 10 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L recall (Z-0200-2023) | Covidien, LP | 2022-11-11 |
| Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN recall (Z-0201-2023) | Covidien, LP | 2022-11-11 |