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Megadyne 96007

by Megadyne Medical Products, Inc.

Megadyne 96007 is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K111262 on 23 May 2012 (1 earlier submission) and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 10614559104415), active as of 23 Oct 2026. 3 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10614559104415 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111262 Date23 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111262 decided 23 May 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10614559104415 listed 4 Sep 2018 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2792-2018 FDA Class II initiated 15 May 2018

    If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

  • 2 recalls, same reason

    • Terminated Z-1942-2018 FDA Class II initiated 11 May 2018
    • Terminated Z-1943-2018 FDA Class II initiated 11 May 2018

    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Timeline

6 dated events

  1. Cleared FDA 510(k) K050579
  2. Cleared FDA 510(k) K111262
  3. Recall initiated FDA recalls Z-1942-2018
  4. Recall initiated FDA recalls Z-1943-2018
  5. Recall initiated FDA recalls Z-2792-2018
  6. Listed FDA GUDID 10614559104415

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Megadyne
Generic name
Electrosurgical cable adaptor
Model / Ref / Catalog
96007
Primary DI / UDI-DI
10614559104415
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical cable adaptor
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical cable adaptor

Cleared under the same submission (K050579)

Cleared under the same submission (K111262)

and 8 more cleared under K111262

Similar devices in this category

Other devices filed under Electrosurgical cable adaptor.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)