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Erbe 20150-260

by Erbe Elektromedizin GmbH

Ref 20150-260

Erbe 20150-260 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-04050147018334), cleared under FDA 510(k) K083608 on 26 Aug 2009 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 04050147018334), 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) K083608

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-04050147018334 Basic UDI-DI 04050147018334UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147018334 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083608 Date26 Aug 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147018334 registered 18 May 2026 Active
  • FDA 510(k) K083608 decided 26 Aug 2009 Active
  • FDA GUDID UDI-DI 04050147018334 listed 9 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083608
  2. Listed FDA GUDID 04050147018334
  3. Registered EUDAMED B-04050147018334

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  • Withdrawn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
HybridKnife® T-Type I-Jet EUDAMED
Erbe GUDID
Generic name
Endoscopic electrosurgical submucosal lift/resection instrument
Device name
HybridKnife probes
Model / Ref / Catalog
20150-260
Primary DI / UDI-DI
04050147018334
Basic UDI-DI
B-04050147018334
510(k) Number
FDA product code
GEI
EMDN code
K0201010301 Open electrosurgery electrodes, single-use
GMDN term
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: Endoscopic electrosurgical submucosal lift/resection instrument

Cleared under the same submission (K083608)

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY ELECTRODES, 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)