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Insert, Bottle Nose Grasper ES0012

by Encision, Inc.

Insert, Bottle Nose Grasper ES0012 is a Class II device made by Encision, Inc., cleared under FDA 510(k) K191612 on 20 Mar 2020 (1 earlier submission) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 10815288011115), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191612 Date20 Mar 2020DecidedStatusActive
United StatesGUDID listing Number10815288011115 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191612 decided 20 Mar 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10815288011115 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

11 dated events

  1. Recall initiated FDA recalls Z-0470-03
  2. Recall initiated FDA recalls Z-1074-04
  3. Recall initiated FDA recalls Z-2400-2011
  4. Recall initiated FDA recalls Z-2398-2011
  5. Recall initiated FDA recalls Z-2397-2011
  6. Recall initiated FDA recalls Z-2396-2011
  7. Recall initiated FDA recalls Z-2399-2011
  8. Recall initiated FDA recalls Z-2395-2011
  9. Listed FDA GUDID 10815288011115
  10. Cleared FDA 510(k) K191612

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Insert, Bottle Nose Grasper
Generic name
Endoscopic electrosurgical electrode, monopolar, reusable
Model / Ref / Catalog
ES0012
Primary DI / UDI-DI
10815288011115
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 (K191612)

and 8 more cleared under K191612

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)