510(k) · Cleared
Recalled · Class II · 2022V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (TM)...
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly US Surgical A Divison of Tyco H · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 3, 2011 as substantially equivalent to K091087 (Surgical Devices, Tyco Healthcare Group LP, 2009) and 5 other predicates after a 10-day review. Its family tree reaches back 3 generations to 1994. It has been recalled 2 times.
- Decided
- Jun 3, 2011
- Review
- 10 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 3 generations to K934738 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK934738 Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc · 1994 · Recalled
- 2 generations backK082659 Modified Endo StichCovidien Lp, Formerly Registered AS United States · 2008
- 1 generation backK090419 Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 2009
- This deviceK111442 V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo…Covidien, Formerly US Surgical A Divison of Tyco H · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934738 | Autosuture Endoscopic Suturing Device | United States Surgical, A Division of Tyco Healthc | 1994 | 2 |
| −2 | K082659 | Modified Endo Stich | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −1 | K090419 | Sils Stitch Endoscopic Suturing Device | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| 0 (this device) | K111442 | V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091087 | Modification to V-Loc 180 Absorbable Wound Closure DeviceSummary page 1…e 21 CFR 876.1500 SILS™ Stitch Endoscopic Suturing Device Endoscopic Tissue Approximation Device 21 CFR 876.1500 V-Loc™ 180 Absorbable Wound Closure Device, Covidien (K091087 and K082662) V-Loc™ Non-Absorbable Wound Closure Device (PBT), Covidien (K103052) Endo Stitch™Endoscopic Suturing Device, Covid… | 2009 |
| * | K082662 | V-Loc 180 Absorbable Wound Closure DeviceSummary page 1…6.1500 SILS™ Stitch Endoscopic Suturing Device Endoscopic Tissue Approximation Device 21 CFR 876.1500 V-Loc™ 180 Absorbable Wound Closure Device, Covidien (K091087 and K082662) V-Loc™ Non-Absorbable Wound Closure Device (PBT), Covidien (K103052) Endo Stitch™Endoscopic Suturing Device, Covidien (K934738… | 2009 |
| * | K103052 | V-Loc (TM) Nonabsorbable Wound Closure DeviceSummary page 1…oximation Device 21 CFR 876.1500 V-Loc™ 180 Absorbable Wound Closure Device, Covidien (K091087 and K082662) V-Loc™ Non-Absorbable Wound Closure Device (PBT), Covidien (K103052) Endo Stitch™Endoscopic Suturing Device, Covidien (K934738) SILS™ Stitch, Covidien (K090419) Addendum to Special 510(k) Premar… | 2010 |
| * | K934738 | Autosuture Endoscopic Suturing DeviceSummary page 1…d Closure Device, Covidien (K091087 and K082662) V-Loc™ Non-Absorbable Wound Closure Device (PBT), Covidien (K103052) Endo Stitch™Endoscopic Suturing Device, Covidien (K934738) SILS™ Stitch, Covidien (K090419) Addendum to Special 510(k) Premarket Notification for , ™Trademark V-Loc™ 180 and V-Loc™ PBT… | 1994 |
| * | K090419 | Sils Stitch Endoscopic Suturing DeviceSummary page 1…7 and K082662) V-Loc™ Non-Absorbable Wound Closure Device (PBT), Covidien (K103052) Endo Stitch™Endoscopic Suturing Device, Covidien (K934738) SILS™ Stitch, Covidien (K090419) Addendum to Special 510(k) Premarket Notification for , ™Trademark V-Loc™ 180 and V-Loc™ PBT Reloads - 06/01/2011 Page 1 of 26… | 2009 |
| * | K955747 | Ussc Nonabsorbable SuturesSummary page 2…"14i Covidien Ic (formerly registered as Tyco Healthcare, LP) USSC Non-absorbable Sutures, Covidien (K955747) DEVICE DESCRIPTION: Absorbable and non-absorbable synthetic suture reloads for… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2022 | Class II | Z-0200-2023 | Process control | 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 the patient, foreign body reaction… |
| Sep 28, 2022 | Class II | Z-0201-2023 | Process control | 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 the patient, foreign body reaction… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K091087.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
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…
Read the full statement (133 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111442: V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (TM)....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111442
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026