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Evotech™ 0101602

by Advanced Sterilization Products Services Inc.

Evotech™ 0101602 is a Class II device made by Advanced Sterilization Products Services Inc., cleared under FDA 510(k) K152189 on 20 Jul 2016 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10705037000289), active as of 23 Oct 2026. 5 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

5 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705037000289 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152189 Date20 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152189 decided 20 Jul 2016 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10705037000289 listed 24 Sep 2016 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0965-2017 FDA Class II initiated 27 Sep 2016

    Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

  • 2 recalls, same reason

    • Terminated Z-1715-2015 FDA Class II initiated 11 May 2015
    • Terminated Z-1714-2015 FDA Class II initiated 11 May 2015

    Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.

    • Terminated Z-1150-2013 FDA Class II initiated 28 Mar 2013

    Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.

    • Terminated Z-1123-2013 FDA Class II initiated 22 Mar 2013

    Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.

Timeline

9 dated events

  1. Cleared FDA 510(k) K082392
  2. Recall initiated FDA recalls Z-1123-2013
  3. Recall initiated FDA recalls Z-1150-2013
  4. Cleared FDA 510(k) K140977
  5. Recall initiated FDA recalls Z-1715-2015
  6. Recall initiated FDA recalls Z-1714-2015
  7. Cleared FDA 510(k) K152189
  8. Listed FDA GUDID 10705037000289
  9. Recall initiated FDA recalls Z-0965-2017

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Evotech™
Generic name
Endoscope channel-opening adaptor
Model / Ref / Catalog
0101602
Primary DI / UDI-DI
10705037000289
510(k) Number
FDA product code
FEB
GMDN term
Endoscope channel-opening adaptor
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope channel-opening adaptor

Cleared under the same submission (K082392)

and 8 more cleared under K082392

Cleared under the same submission (K140977)

and 8 more cleared under K140977

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)