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Beamer ESU CE200

by KLS Martin GmbH + Co. KG

Beamer ESU CE200 is an electrosurgical system generator (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by KLS Martin GmbH + Co. KG, cleared under FDA 510(k) K081678 on 29 Jul 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04057607000106), active as of 21 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 21 Oct 2026

Documents

510(k) K081678

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04057607000106 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK081678 Date29 Jul 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081678 decided 29 Jul 2008 Active
  • FDA GUDID UDI-DI 04057607000106 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081678
  2. Listed FDA GUDID 04057607000106

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Electrosurgical system generator
Model / reference
CE200
Primary DI / UDI-DI
04057607000106
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

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Other devices filed under Electrosurgical system generator.

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Properties

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