Laparoscopic Electrosurg Device W/Irriga & Aspira

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922509 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bitx Probes

  Class II

  FDA 510(k) K993412 Active Cleared 31 Mar 2000

• Model 8750 Bipolar/Monopolar Electrosurgical Gene.

  Class II

  FDA 510(k) K895841 Active Cleared 15 Nov 1989

• Bicoag Coagulating Forceps

  Class II

  FDA 510(k) K971565 Active Cleared 12 Mar 1998

• Laparoscopic Electrosurgical Device

  Class II

  FDA 510(k) K904993 Active Cleared 25 Jan 1991

• Plasmakinetic Generator

  Class II

  FDA 510(k) K003060 Active Cleared 31 Oct 2000

• Evershears Bipolar Scissors

  Class II

  FDA 510(k) K000496 Active Cleared 24 Apr 2000

See all devices from Everest Medical Corp. →

• What is the laparoscopic electrosurgical device with irrigation and aspiration used for?

  It is used for cutting, coagulating, and removing tissue during minimally invasive laparoscopic surgery, combining electrosurgical energy with fluid irrigation and suction to improve visualization and tissue management in general and plastic surgery settings.

• Is the laparoscopic electrosurgical device with irrigation and aspiration reusable or single-use?

  The device is supplied as a reusable instrument, meaning it is designed to be cleaned, sterilized, and used multiple times across procedures, as indicated in the device description.

• What regulatory pathway was used for the laparoscopic electrosurgical device with irrigation and aspiration?

  The device received FDA 510(k) clearance under submission K922509 on October 1, 1992, and was determined to be substantially equivalent to a legally marketed predicate device.

• What product code classifies the laparoscopic electrosurgical device with irrigation and aspiration?

  The device is classified under product code GEI, which pertains to electrosurgical cutting and coagulation accessories, as specified in the authorization and device data.

• Who is the manufacturer of the laparoscopic electrosurgical device with irrigation and aspiration?

  The device is manufactured by Everest Medical Corp., located at 13755 First Ave. N., Minneapolis, MN 55441, as listed in the device specifications and applicant information.