VLOC9ABSORBABLE WOUND CLOSURE DEVICE— 510(k) K100257

Clearance details

Applicant

Surgical Devices, A Division of Tyco Healthcare

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2010-01-28

Decision date

2010-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Haven, CT, US

• K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture2026-06-25
• K253530 — Trexon Monofilament Synthetic Absorbable Suture2026-05-28
• K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture2026-02-06
• K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2025-12-22
• K253620 — TroClose 12002025-12-16

• K100242 — AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER2010-02-17
• K093408 — V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE2009-11-12

Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2918-2026 — V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115Class II·Ongoing·Covidien, LP·20260624

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100257.