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Adapter, SIE, Applied ES3810

by Encision, Inc.

Adapter, SIE, Applied ES3810 is a Class II device made by Encision, Inc., cleared under FDA 510(k) K100711 on 9 Jun 2010 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 10815288010941), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K100711

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 Number10815288010941 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100711 Date9 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100711 decided 9 Jun 2010 Active
  • FDA GUDID UDI-DI 10815288010941 listed 31 Aug 2016 Listed

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-3097-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2011
    • Terminated Z-3096-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2011
    • Terminated Z-3094-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2011
    • Terminated Z-3095-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2011
    • Terminated Z-3093-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2011

    Electrode tips have been reported breaking off during use or cleaning.

Timeline

7 dated events

  1. Cleared FDA 510(k) K100711
  2. Recall initiated FDA recalls Z-3097-2011
  3. Recall initiated FDA recalls Z-3096-2011
  4. Recall initiated FDA recalls Z-3094-2011
  5. Recall initiated FDA recalls Z-3095-2011
  6. Recall initiated FDA recalls Z-3093-2011
  7. Listed FDA GUDID 10815288010941

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Adapter, SIE, Applied
Generic name
Surgical irrigation/aspiration handpiece, reusable
Model / Ref / Catalog
ES3810
Primary DI / UDI-DI
10815288010941
510(k) Number
FDA product code
GEI
GMDN term
Surgical irrigation/aspiration handpiece, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K100711)

and 3 more cleared under K100711

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

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)