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Monopolar Laparoscopic Electrodes W/Eletroshield

by Electroscope, Inc.

510(k) K912780

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

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 NumberK912780 Date30 Dec 1991ClearedStatusActive

Recalls

8 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2400-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011
    • Terminated Z-2398-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011
    • Terminated Z-2397-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011
    • Terminated Z-2396-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011
    • Terminated Z-2399-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011
    • Terminated Z-2395-2011 FDA Unclassified (pre-2012) initiated 7 Apr 2011

    Sterility may be compromised due to holes in packaging.

    • Terminated Z-1074-04 FDA Unclassified (pre-2012) initiated 11 Jun 2004

    Electrosurgical tip may break or come off during use.

    • Terminated Z-0470-03 FDA Unclassified (pre-2012) initiated 15 Jan 2003

    Reports of needle fixed-tip electrodes becoming loose or breaking off.

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  • Withdrawn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

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