LigaSure LF2019: 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	Number0763000B00028358P Basic UDI-DI 10884521741096UDI-DI	Date18 Jun 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK202917	Date23 Mar 2021Decided	StatusActive
United States	GUDID listing GUDID	Number10884521741096 UDI-DI	Date21 Mar 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK173281	Date2 Mar 2018Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0763000B00028358P — open Devices and search for it
AccessGUDID record UDI-DI 10884521741096
FDA 510(k) database 510(k) number K202917
FDA 510(k) database 510(k) number K173281

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0763000B00028358P registered 18 Jun 2026 Active
FDA 510(k) K202917 decided 23 Mar 2021 Active· +1 more in the status table
FDA GUDID UDI-DI 10884521741096 listed 21 Mar 2018 Listed

Timeline

4 dated events

2 Mar 2018 Cleared FDA 510(k) K173281
21 Mar 2018 Listed FDA GUDID 10884521741096
23 Mar 2021 Cleared FDA 510(k) K202917
18 Jun 2026 Registered EUDAMED 0763000B00028358P

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Withdrawn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: LigaSureTM EUDAMED
LigaSure GUDID
Generic name: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device name: LigaSure Exact
Model / reference: LF2019

Primary DI / UDI-DI: 10884521741096
Basic UDI-DI: 0763000B00028358P
510(k) Number: K173281
K202917
FDA product code: GEI
EMDN code: K0201010201 Open electrosurgery dissectors, single-use
GMDN term: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 878.4400
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Size: Outer Diameter — 20.6 Millimeter
Length — 21 Centimeter

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.