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Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167

by Celon AG Medical Instruments

510(k) K073207

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073207 Date8 May 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0747-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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