GeniSurge 533-005-905

• FDA 510(k) K061417 decided 10 Oct 2006 Active
• FDA GUDID UDI-DI 00877972001980 listed 5 May 2017 Listed

1. 10 Oct 2006 Cleared FDA 510(k) K061417
2. 5 May 2017 Listed FDA GUDID 00877972001980

Trade name

GeniSurge

Generic name

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Model / reference

533-005-905

Primary DI / UDI-DI

00877972001980

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

Other devices filed under Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.

• Cystotome G30550 CST-10 by Cook Ireland, Ltd.
• Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07203A N5778730 by Olympus Medical Systems Corporation
• Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07201S N5778230 by Olympus Medical Systems Corporation
• CAPTIFLEX M00562400 by Boston Scientific
• TruPass, FX Wire P3043F by Conmed Corporation
• Epix Electrosurgical Probe with Smoke Evacuation - Angled Needle Tip CW003 by APPLIED MEDICAL RESOURCES CORP.
• Duette G34036 DT-6 by Cook Ireland, Ltd.
• CAPTIVATOR II M00561290 by Boston Scientific
• CoinTip 00711110 by US Endoscopy
• Epix Electrosurgical Probe with Smoke Evacuation -Straight L-Hook CW005 by APPLIED MEDICAL RESOURCES CORP.

• GeniPort 100-105-102 Open recall

  Class I

  FDA 510(k) K982472 Active Cleared 4 Feb 1999 GUDID on market

• Natura 210-110-252 Open recall

  Class I

  FDA 510(k) K982472 Active Cleared 4 Feb 1999 GUDID on market

• 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

See all devices from Genicon →