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Megadyne 1300SJ

by Megadyne Medical Products, Inc.

Ref 1300SJ

Megadyne 1300SJ is a device classified as Class I in the EU and Class II in the US made by Megadyne Medical Products, Inc., registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 0614559a00007BV), cleared under FDA 510(k) K050579 on 24 Mar 2005 and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 10614559105283), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050579

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00007BV Basic UDI-DI 10614559105283UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559105283 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK050579 Date24 Mar 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00007BV registered 24 Oct 2025 Active
  • FDA 510(k) K050579 decided 24 Mar 2005 Active
  • FDA GUDID UDI-DI 10614559105283 listed 4 Sep 2018 Listed

Recalls

1 recall · 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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K050579
  2. Recall initiated FDA recalls Z-2792-2018
  3. Listed FDA GUDID 10614559105283
  4. Registered EUDAMED 0614559a00007BV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Megadyne
Generic name
Electromechanical device/system transport trolley
Device name
MEGADYNE MEGA Cart
Model / Ref / Catalog
1300SJ
Primary DI / UDI-DI
10614559105283
Basic UDI-DI
0614559a00007BV
Direct marketing DI
10614559105283
510(k) Number
FDA product code
GEI
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Electromechanical device/system transport trolley
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electromechanical device/system transport trolley

Cleared under the same submission (K050579)

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (23, all answered No)