# K111442: V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (TM)...

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Jun 3, 2011 after 10 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934738 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091087: Modification to V-Loc 180 Absorbable Wound Closure Device, Surgical Devices, Tyco Healthcare Group LP (2009) Summary page 1.
- K082662: V-Loc 180 Absorbable Wound Closure Device, Surgical Devices, Tyco Healthcare Group LP (2009) Summary page 1.
- K103052: V-Loc (TM) Nonabsorbable Wound Closure Device, Covidien, LLC (2010) Summary page 1.
- K934738: Autosuture Endoscopic Suturing Device, United States Surgical, A Division of Tyco Healthc (1994) Summary page 1.
- K090419: Sils Stitch Endoscopic Suturing Device, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.
- K955747: Ussc Nonabsorbable Sutures, United States Surgical, A Division of Tyco Healthc (1996) Summary page 2.

## Recalls of this device
- Sep 28, 2022 · Class II · Z-0200-2023: Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in th
- Sep 28, 2022 · Class II · Z-0201-2023: Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in th

## Indications for use
The V-LaoCTM 180 absorbable reloads are intended for use with the Endo Stitch TM suturing device and SILS TM Stitch suturing device. The Endo StitchTM suturing device and SILSTM Stitch suturing device, when used with the reloads, have application in endloscopic surgery for the placement of running stitches in soft tissue. The V-LocTM 180 absorbable reloads are indicated for soft tissue approximation where use of an absorbable suture is appropriate. The V-LocTM PBT non-absorbable reloads are intended for use with the Endo StitchTM suturing device and SILS T M Stitch suturing device. The Endo StitchTM suturing device and SILS TM Stitch suturing device, when used with the reloads, have application in endloscopic surgery for the placement of running stitches in soft tissue. The V-LocTM PBT non-absorbable reloads are indicated for soft tissue approximation.

Source page: https://510kreport.com/device/K111442
Methodology: https://510kreport.com/methodology