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Disposable Sheath ES0150-45

by Encision, Inc.

Disposable Sheath ES0150-45 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 10815288010682), 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 Number10815288010682 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 10815288010682 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 10815288010682
  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
Disposable Sheath
Generic name
Electrosurgical system monitor/shield
Model / Ref / Catalog
ES0150-45
Primary DI / UDI-DI
10815288010682
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system monitor/shield
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Length — 45 Centimeter

Related devices

Category: Electrosurgical system monitor/shield

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

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

Other devices from Encision, Inc.

See all devices from Encision, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)