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Erbe 20150-215

by Erbe Elektromedizin GmbH

Ref 20150-215

Erbe 20150-215 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 18 May 2026 (Basic UDI-DI B-04050147020092), cleared under FDA 510(k) K243120 on 20 Jun 2025 (1 earlier submission) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04050147020092), 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) K243120

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04050147020092 Basic UDI-DI 04050147020092UDI-DIDate18 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243120 Date20 Jun 2025DecidedStatusActive
United StatesGUDID listing GUDID Number04050147020092 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147020092 registered 18 May 2026 Active
  • FDA 510(k) K243120 decided 20 Jun 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04050147020092 listed 16 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K143306
  2. Listed FDA GUDID 04050147020092
  3. Cleared FDA 510(k) K243120
  4. Registered EUDAMED B-04050147020092

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  • Withdrawn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
HybridAPC Sonde EUDAMED
Erbe GUDID
Generic name
Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Device name
HybridAPC probes
Model / Ref / Catalog
20150-215
Primary DI / UDI-DI
04050147020092
Basic UDI-DI
B-04050147020092
510(k) Number
FDA product code
GEI
EMDN code
K02040199 Argon gas surgery instruments, single-use- other
GMDN term
Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
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
Size
Length — 1.900 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 submucosal lift/resection instrument

Cleared under the same submission (K143306)

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)