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Erbe 20132-321

by Erbe Elektromedizin GmbH

Ref 20132-321

Erbe 20132-321 is a device classified as Class IIb in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 4050147FiAPC-plus-SU-V4), cleared under FDA 510(k) K242044 on 26 Aug 2024 and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 04050147023536), 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) K242044

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 Number4050147FiAPC-plus-SU-V4 Basic UDI-DI 04050147023536UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147023536 UDI-DI Date11 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242044 Date26 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4050147FiAPC-plus-SU-V4 registered 13 May 2026 Active
  • FDA 510(k) K242044 decided 26 Aug 2024 Active
  • FDA GUDID UDI-DI 04050147023536 listed 11 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242044
  2. Listed FDA GUDID 04050147023536
  3. Registered EUDAMED 4050147FiAPC-plus-SU-V4

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  • Withdrawn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
FiAPC® plus A EUDAMED
Erbe GUDID
Generic name
Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Model / Ref / Catalog
20132-321
Primary DI / UDI-DI
04050147023536
Basic UDI-DI
4050147FiAPC-plus-SU-V4
Direct marketing DI
04050147023536
510(k) Number
FDA product code
GEI
EMDN code
K02040199 Argon gas surgery instruments, single-use- other
GMDN term
Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 2.2 Meter

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.

Related devices

Category: Inert gas-enhanced endoscopic electrosurgical electrode, single-use

Cleared under the same submission (K242044)

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH ARGON GAS GENERATOR, SINGLE-USE.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

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