Skip to content

Magnatek Electrosurgical Units Models, Esu-10, Esu-15

by Magna Advanced Technologies, Inc.

510(k) K981416

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981416 Date24 Jun 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Magna Advanced Technologies, Inc.

  • Magnatek C-300

    Class II

  • Magnatek 30

    Class II

  • Mtek-1400

    Class II

  • Magnatek 40

    Class II

  • Mtek-1000

    Class II

  • MAGNATEK80

    Class II