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Wallach 909104

by CooperSurgical, Inc.

Wallach 909104 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K963653 on 11 Jun 1997 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 60888937011380), active as of 23 Oct 2026. 9 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

5 ongoing

This device is named in the recall

Documents

510(k) K963653

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 Number60888937011380 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK963653 Date11 Jun 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K963653 decided 11 Jun 1997 Active
  • FDA GUDID UDI-DI 60888937011380 listed 28 Sep 2016 Listed

Recalls

9 recalls · 5 ongoing · FDA

    • Ongoing Z-0263-2022 FDA Class II initiated 29 Sep 2021

    XXX

  • 4 recalls, same reason

    • Ongoing Z-0262-2022 FDA Class II initiated 29 Sep 2021
    • Ongoing Z-0259-2022 FDA Class II initiated 29 Sep 2021
    • Ongoing Z-0261-2022 FDA Class II initiated 29 Sep 2021
    • Ongoing Z-0260-2022 FDA Class II initiated 29 Sep 2021

    Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

  • 3 recalls, same reason

    • Terminated Z-0601-2020 FDA Class II initiated 16 Oct 2019
    • Terminated Z-0602-2020 FDA Class II initiated 16 Oct 2019
    • Terminated Z-0600-2020 FDA Class II initiated 16 Oct 2019

    Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.

    • Terminated Z-2057-2019 FDA Class II initiated 18 Jun 2019

    The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

Timeline

11 dated events

  1. Listed FDA GUDID 60888937011380
  2. Recall initiated FDA recalls Z-2057-2019
  3. Recall initiated FDA recalls Z-0601-2020
  4. Recall initiated FDA recalls Z-0602-2020
  5. Recall initiated FDA recalls Z-0600-2020
  6. Recall initiated FDA recalls Z-0263-2022
  7. Recall initiated FDA recalls Z-0262-2022
  8. Recall initiated FDA recalls Z-0259-2022
  9. Recall initiated FDA recalls Z-0261-2022
  10. Recall initiated FDA recalls Z-0260-2022

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
Wallach
Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Model / reference
909104
Primary DI / UDI-DI
60888937011380
510(k) Number
FDA product code
HGI
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class II
Regulation number
884.4120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Cleared under the same submission (K963653)

Similar devices in this category

Other devices filed under Open-surgery electrosurgical electrode, monopolar, single-use.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

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