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Horizontal Handle without Ratchet

by Surgical Innovations Ltd.

Ref 101-41000

Horizontal Handle without Ratchet (101-41000) is a device classified as Class IIa and Class IIb in the EU and Class II in the US made by Surgical Innovations Ltd., registered in EUDAMED on 9 Mar 2023 (Basic UDI-DI 5051986SIRUH4E), cleared under FDA 510(k) K063485 on 1 Dec 2006 and listed in FDA GUDID since 23 Sep 2020 (UDI-DI 05051986000039), active as of 24 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063485

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number5051986SIRUH4E Basic UDI-DI 05051986000039UDI-DIDate9 Mar 2023RegisteredStatusActive
European UnionCE/MDR EUDAMED Number5051986SIRUH4E Basic UDI-DI 05051986000039UDI-DIDate9 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05051986000039 UDI-DI Date23 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063485 Date1 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5051986SIRUH4E registered 9 Mar 2023 Active· +1 more in the status table
  • FDA 510(k) K063485 decided 1 Dec 2006 Active
  • FDA GUDID UDI-DI 05051986000039 listed 23 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063485
  2. Listed FDA GUDID 05051986000039
  3. Registered EUDAMED 5051986SIRUH4E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Horizontal Handle without Ratchet EUDAMED
Logic - Laparoscopic Instrument System GUDID
Generic name
Electrocautery system handpiece
Device name
Logic Handle
Model / reference
101-41000
Primary DI / UDI-DI
05051986000039
Basic UDI-DI
5051986SIRUH4E, B-05051986000039
Direct marketing DI
05051986000039
510(k) Number
FDA product code
GEI
EMDN code
L180302 Endoscopic electrosurgery handpieces, reusable
GMDN term
Electrocautery system handpiece
Device class
Class IIa EUDAMED
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa and Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Manufacturer details

EUDAMED SRN
GB-MF-000012187
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE.

Other devices from Surgical Innovations Ltd.

See all devices from Surgical Innovations Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)