Skip to content

Erbe 20132-209

by Erbe Elektromedizin GmbH

Erbe 20132-209 is an inert gas-enhanced electrosurgical handpiece (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Erbe Elektromedizin GmbH, cleared under FDA 510(k) K024047 on 8 Jan 2003 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 04050147001329), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K024047

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04050147001329 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK024047 Date8 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024047 decided 8 Jan 2003 Active
  • FDA GUDID UDI-DI 04050147001329 listed 10 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024047
  2. Listed FDA GUDID 04050147001329

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Erbe
Generic name
Inert gas-enhanced electrosurgical handpiece
Model / Ref / Catalog
20132-209
Primary DI / UDI-DI
04050147001329
510(k) Number
FDA product code
GEI
GMDN term
Inert gas-enhanced electrosurgical handpiece
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inert gas-enhanced electrosurgical handpiece

Cleared under the same submission (K024047)

Similar devices

Also classified as Inert gas-enhanced electrosurgical handpiece.

Similar devices

Other devices filed under FDA product code GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES).

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)