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Mentor Wet-Field II AC Coagulator, 22-1305

by Mentor O & O, Inc.

510(k) K911160

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK911160 Date2 May 1991ClearedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

    • Ongoing Z-1594-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    • Ongoing Z-1281-2022 FDA Class II initiated 26 Apr 2022

    Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250

    • Terminated Z-1539-2018 FDA Class II initiated 26 Feb 2018

    Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

    • Terminated Z-1801-2018 FDA Class II initiated 26 Feb 2018

    Products were packaged with incorrect labeling,

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Mentor(R) Wet-Field(R) II Ac Coagulator, 22-1305
510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mentor Wet-Field II AC Coagulator, 22-1305, is an electrosurgical cutting and coagulation device. It is intended to remove tissue and control bleeding through the use of high-frequency electrical current.

This device is classified as an electrosurgical cutting and coagulation accessory under product code GEI. It has received FDA 510(k) clearance, identified by K911160, and is categorized as a Class II device subject to special controls.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Mentor Wet-Field II AC Coagulator?

    This device is an electrosurgical instrument designed to perform tissue removal and manage bleeding during surgical procedures. It achieves these clinical outcomes by applying high-frequency electrical current to the target site.

  • How is this device classified for regulatory purposes?

    The Mentor Wet-Field II AC Coagulator is categorized as a Class II electrosurgical cutting and coagulation accessory under product code GEI. It has received FDA 510(k) clearance under reference number K911160, confirming it is substantially equivalent to existing devices.

  • Who is the manufacturer of the 22-1305 model?

    The device is manufactured by Mentor O & O, Inc., based in Norwell, Massachusetts. The company submitted the device for FDA review, resulting in a traditional 510(k) clearance decision.