Skip to content

Surgitron 4.0 Dual Rf S5-Iec

by Ellman International, Inc.

510(k) K123366

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK123366 Date12 Jul 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0748-2017 FDA Class II initiated 7 Sep 2016

    Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.

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  • Withdrawn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 Ellman International, Inc.