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355mm Petelin

by Surgical Innovations Ltd.

Ref 101-49029

355mm Petelin (101-49029) is a device classified as Class IIb in the EU and Class II in the US made by Surgical Innovations Ltd., registered in EUDAMED on 21 Apr 2023 (Basic UDI-DI B-05051986007250), cleared under FDA 510(k) K111986 on 26 Jan 2012 and listed in FDA GUDID since 23 Sep 2020 (UDI-DI 05051986007250), active as of 22 Oct 2026.

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

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111986

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05051986007250 Basic UDI-DI 05051986007250UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05051986007250 UDI-DI Date23 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111986 Date26 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05051986007250 registered 21 Apr 2023 Active
  • FDA 510(k) K111986 decided 26 Jan 2012 Active
  • FDA GUDID UDI-DI 05051986007250 listed 23 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111986
  2. Listed FDA GUDID 05051986007250
  3. Registered EUDAMED B-05051986007250

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
355mm Petelin EUDAMED
Logic - Laparoscopic Instrument System GUDID
Generic name
Endoscopic electrosurgical electrode, monopolar, reusable
Model / reference
101-49029
Primary DI / UDI-DI
05051986007250
Basic UDI-DI
B-05051986007250
510(k) Number
FDA product code
GEI
EMDN code
L1899 Electrosurgery instruments, reusable - other
GMDN term
Endoscopic electrosurgical electrode, monopolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
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 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.

Manufacturer details

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

Related devices

Category: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER.

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 (18, all answered No)