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Conmed R Sabre Genesis Tm Electrosurgical Unit; Coned R Sabre Genesis Tm Electrosurgical Unit (230V); Conmed Hyfresurg O

by Conmed Corporation

510(k) K103665

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 NumberK103665 Date16 Feb 2011ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Conmed Sabre Genesis and HyfreSurg OP are electrosurgical generators designed for use in open and laparoscopic surgery. These units are also intended for use in office-based surgical procedures.

This device is supplied as an electrosurgical unit and is subject to FDA 510K authorization. It is intended for professional use in clinical settings as specified by the manufacturer.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Questions

AI-generated answers, 22 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 are the Conmed Sabre Genesis and HyfreSurg OP units used for?

    These electrosurgical generators are designed to perform surgical procedures in open and laparoscopic environments. They are also intended for use in office-based surgical settings by professional clinicians.

  • What is the regulatory status of these electrosurgical units?

    The Conmed Sabre Genesis and HyfreSurg OP units are subject to FDA 510K authorization. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of these electrosurgical generators?

    These units are manufactured by the Conmed Corporation, located in Centennial, Colorado. The company manages the production and distribution of these devices for clinical use.