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Fixed Tip Electrode, Square-L ES3514B

by Encision, Inc.

Fixed Tip Electrode, Square-L ES3514B is a Class II device made by Encision, Inc., cleared under FDA 510(k) K912780 on 30 Dec 1991 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 10815288010477), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

510(k) K912780

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10815288010477 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912780 Date30 Dec 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912780 decided 30 Dec 1991 Active
  • FDA GUDID UDI-DI 10815288010477 listed 31 Aug 2016 Listed

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.

Timeline

10 dated events

  1. Cleared FDA 510(k) K912780
  2. Recall initiated FDA recalls Z-0470-03
  3. Recall initiated FDA recalls Z-1074-04
  4. Recall initiated FDA recalls Z-2400-2011
  5. Recall initiated FDA recalls Z-2398-2011
  6. Recall initiated FDA recalls Z-2397-2011
  7. Recall initiated FDA recalls Z-2396-2011
  8. Recall initiated FDA recalls Z-2399-2011
  9. Recall initiated FDA recalls Z-2395-2011
  10. Listed FDA GUDID 10815288010477

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fixed Tip Electrode, Square-L
Generic name
Endoscopic electrosurgical electrode, monopolar, reusable
Model / Ref / Catalog
ES3514B
Primary DI / UDI-DI
10815288010477
510(k) Number
FDA product code
GEI
GMDN term
Endoscopic electrosurgical electrode, monopolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic electrosurgical electrode, monopolar, reusable

Cleared under the same submission (K912780)

and 8 more cleared under K912780

Similar devices in this category

Other devices filed under Endoscopic electrosurgical electrode, monopolar, reusable.

Other devices from Encision, Inc.

See all devices from Encision, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)