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Bipolar Forceps 80-201-03

by Spiggle & Theis Medizintechnik GmbH

Ref 80-201-03

Bipolar Forceps 80-201-03 is a device classified as Class IIb in the EU and Class II in the US made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250381892800), cleared under FDA 510(k) K101080 on 21 Jun 2010 and listed in FDA GUDID since 7 Jun 2019 (UDI-DI 04250381892800), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101080

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/MDD EUDAMED NumberB-04250381892800 Basic UDI-DI 04250381892800UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381892800 UDI-DI Date7 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101080 Date21 Jun 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04250381892800 registered 30 Sep 2026 Active
  • FDA 510(k) K101080 decided 21 Jun 2010 Active
  • FDA GUDID UDI-DI 04250381892800 listed 7 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101080
  2. Listed FDA GUDID 04250381892800
  3. Registered EUDAMED B-04250381892800

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  • Withdrawn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
Bipolar Forceps
Generic name
Endoscopic electrosurgical electrode, bipolar, reusable
Model / Ref / Catalog
80-201-03
Primary DI / UDI-DI
04250381892800
Basic UDI-DI
B-04250381892800
510(k) Number
FDA product code
GEI
EMDN code
L180401 Open electrosurgery forceps, reusable
GMDN term
Endoscopic electrosurgical electrode, bipolar, 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
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 16 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical electrode, bipolar, reusable

Cleared under the same submission (K101080)

and 8 more cleared under K101080

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

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