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LigaSure MRASILF19

by Covidien LP

Ref MRASILF19

LigaSure MRASILF19 is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 0763000B00031207E), cleared under FDA 510(k) K261070 on 15 Sep 2026 and listed in FDA GUDID since 1 Oct 2026 (UDI-DI 10884521740150), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K261070

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00031207E Basic UDI-DI 10884521740150UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521740150 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK261070 Date15 Sep 2026DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00031207E registered 19 Oct 2026 Active
  • FDA 510(k) K261070 decided 15 Sep 2026 Active
  • FDA GUDID UDI-DI 10884521740150 listed 1 Oct 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K261070
  2. Listed FDA GUDID 10884521740150
  3. Registered EUDAMED 0763000B00031207E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • 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  • Withdrawn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
Robotic endoscopic electrosurgical instrument, bipolar, single-use
Device name
LigaSure RAS Maryland
Model / reference
MRASILF19
Primary DI / UDI-DI
10884521740150
Basic UDI-DI
0763000B00031207E
510(k) Number
FDA product code
GEI
EMDN code
K0201010202 Laparoscopic and thoracoscopic electrosurgery dissectors, single-use
GMDN term
Robotic endoscopic electrosurgical instrument, 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
Length — 44 Centimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K261070)

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)