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MSD Bipolar Forceps

by Medtronic Sofamor Danek, Inc.

510(k) K061635

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 NumberK061635 Date5 Sep 2006ClearedStatusActive

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  • Withdrawn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
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

This is an electrosurgical cutting and coagulation device with accessories, classified under product code GEI and regulation number 21 CFR 878.4400. It is a bipolar forceps designed for use in general and plastic surgery procedures.

The device received FDA 510(k) clearance (K061635) on September 5, 2006, as substantially equivalent to a predicate device. It is manufactured by Medtronic Sofamor Danek, Inc., and is intended for use in electrosurgical applications as defined by its classification.

Other devices from Medtronic Sofamor Danek, Inc.

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Questions

AI-generated answers, 6 Oct 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 MSD BIPOLAR FORCEPS used for?

    The MSD BIPOLAR FORCEPS is an electrosurgical cutting and coagulation device with accessories, designed for use in general and plastic surgery procedures as defined by its classification under product code GEI and regulation 21 CFR 878.4400.

  • How was the MSD BIPOLAR FORCEPS cleared for market?

    The device received FDA 510(k) clearance (K061635) on September 5, 2006, as substantially equivalent to a predicate device through a traditional review process, based on its intended use in electrosurgical applications.

  • Who manufactures the MSD BIPOLAR FORCEPS and where is it located?

    The MSD BIPOLAR FORCEPS is manufactured by Medtronic Sofamor Danek, Inc., located at 1800 Pyramid Pl., Memphis, TN 38132, United States, with Richard W Treharne as the contact.