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Selectone Universal Plus Munro Laparoscopic Loop Electrode Model 60-5276 Series

by Conmedcorp

510(k) K961197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK961197 Date21 Jun 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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, 19 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 Selectone Universal Plus Munro Laparoscopic Loop Electrode Model 60-5276 Series is an electrosurgical cutting and coagulation device designed for laparoscopic procedures. It delivers high-frequency electrical current to excise tissue and control bleeding during minimally invasive surgery.

This device is supplied as a reusable instrument and is classified under the GEI product code for electrosurgical cutting and coagulation accessories. It holds an FDA 510(k) clearance (K961197) and is intended for use in general and plastic surgery settings, adhering to traditional review standards.

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