GeniSurge 533-005-950

• FDA 510(k) K061417 decided 10 Oct 2006 Active
• FDA GUDID UDI-DI 00877972002208 listed 5 May 2017 Listed

1. 10 Oct 2006 Cleared FDA 510(k) K061417
2. 5 May 2017 Listed FDA GUDID 00877972002208

Trade name

GeniSurge

Generic name

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Model / reference

533-005-950

Primary DI / UDI-DI

00877972002208

510(k) Number

K061417 ↗

FDA product code

GEI

GMDN term

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Device class

Class II

Regulation number

878.4400

GUDID distribution status

In Commercial Distribution

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

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• GeniPort 100-105-102 Open recall

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• Natura 210-110-252 Open recall

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• NanoSurge 520-063-950

  Class I

  FDA 510(k) K061417 Active Cleared 10 Oct 2006 GUDID on market

• GeniSurge 533-005-930T

  Class II

  FDA 510(k) K061417 Active Cleared 10 Oct 2006 GUDID on market

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