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Erbe 10140-610

by Erbe Elektromedizin GmbH

Erbe 10140-610 is an electrosurgical system generator (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Erbe Elektromedizin GmbH, cleared under FDA 510(k) K083452 on 31 Dec 2008 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04050147017665), 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) K083452

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 Number04050147017665 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK083452 Date31 Dec 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083452 decided 31 Dec 2008 Active
  • FDA GUDID UDI-DI 04050147017665 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083452
  2. Listed FDA GUDID 04050147017665

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  • Withdrawn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
Electrosurgical system generator
Model / Ref / Catalog
10140-610
Primary DI / UDI-DI
04050147017665
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical system generator

Cleared under the same submission (K083452)

and 8 more cleared under K083452

Similar devices in this category

Other devices filed under Electrosurgical system generator.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)