V-Loc VLOCN008L: CE/MDR Class IIb, Covidien LP

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0763000B000057688 Basic UDI-DI 10884521073609UDI-DI	Date12 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number10884521073609 UDI-DI	Date2 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK111442	Date3 Jun 2011Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0763000B000057688 — open Devices and search for it
AccessGUDID record UDI-DI 10884521073609
FDA 510(k) database 510(k) number K111442

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0763000B000057688 registered 12 Oct 2026 Active
FDA 510(k) K111442 decided 3 Jun 2011 Active
FDA GUDID UDI-DI 10884521073609 listed 2 Sep 2015 Listed

Recalls

2 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0200-2023 FDA Class II initiated 28 Sep 2022 on shared 510(k) K111442
- Ongoing Z-0201-2023 FDA Class II initiated 28 Sep 2022 on shared 510(k) K111442
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, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

3 Jun 2011 Cleared FDA 510(k) K111442
2 Sep 2015 Listed FDA GUDID 10884521073609
28 Sep 2022 Recall initiated FDA recalls Z-0200-2023
28 Sep 2022 Recall initiated FDA recalls Z-0201-2023
12 Oct 2026 Registered EUDAMED 0763000B000057688

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: V-LocTM EUDAMED
V-Loc GUDID
Generic name: Barbed polyester suture, non-antimicrobial
Device name: V-Loc™ PBT Non-absorbable Reload
Model / reference: VLOCN008L

Primary DI / UDI-DI: 10884521073609
Basic UDI-DI: 0763000B000057688
510(k) Number: K111442
FDA product code: GAT
EMDN code: H010201010201 Polyester and derivatives monofilament with needle
GMDN term: Barbed polyester suture, non-antimicrobial

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 878.5000
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Size: Length — 8 Inch

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.