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Macan MC-4A

by Macan Manufacturing 3 variants

Macan MC-4A is a Class II device made by Macan Manufacturing, cleared under FDA 510(k) K050735 on 23 May 2005 and listed in FDA GUDID since 9 Nov 2016 (UDI-DI 00851683006014), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K050735

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851683006014 UDI-DI Date9 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050735 Date23 May 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050735 decided 23 May 2005 Active
  • FDA GUDID UDI-DI 00851683006014 listed 9 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050735
  2. Listed FDA GUDID 00851683006014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Macan
Generic name
Electrosurgical system
Model / reference
MC-4A
Primary DI / UDI-DI
00851683006014
510(k) Number
FDA product code
EKZ
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
872.4920
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Electrosurgical system.

Other devices from Macan Manufacturing

  • Macan MC-6A

    Class II
  • Macan BCO

    Class II
  • Macan R-L27

    Class II
  • Macan R-L19

    Class II

See all devices from Macan Manufacturing →

Properties

  • Sterilise before use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)