GeniSurge 533-105-910

• FDA 510(k) K061417 decided 10 Oct 2006 Active
• FDA GUDID UDI-DI 00877972004615 listed 5 May 2017 Listed

1. 10 Oct 2006 Cleared FDA 510(k) K061417
2. 5 May 2017 Listed FDA GUDID 00877972004615

Trade name

GeniSurge

Generic name

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Model / reference

533-105-910

Primary DI / UDI-DI

00877972004615

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.

• Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203S N5779430 by Olympus Medical Systems Corporation
• Single Use 3-Lumen Sphincterotome V KD-V411M-1520 N5411630 by Olympus Medical Systems Corporation
• CAPTIFLEX M00562420 by Boston Scientific
• CoinTip 00711415 by US Endoscopy
• TruPass, FX Wire P2043F by Conmed Corporation
• BE-ST ElectroCautery Pencil 9569575 by Lacey Manufacturing Company, LLC
• Epix Electrosurgical Probe with Smoke Evacuation - Angled Spatula Tip CW001 by APPLIED MEDICAL RESOURCES CORP.
• CoinTip 00711416 by US Endoscopy
• TRUPASS T3043F by Conmed Corporation
• Epix Laparoscopic Scissors CB030 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 →