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USA Elite MLE-28-012

by Gyrus Acmi, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821925038486 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3300-2026 FDA Class II initiated 24 Aug 2026 on shared 510(k) K890328
    • Ongoing Z-3299-2026 FDA Class II initiated 24 Aug 2026 on shared 510(k) K890328

    There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

    • Ongoing Z-2720-2026 FDA Class II initiated 5 May 2026 on shared 510(k) K890328

    Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

  • 2 recalls, same reason

    • Ongoing Z-2140-2025 FDA Class II initiated 18 Jun 2025 on shared 510(k) K890328
    • Ongoing Z-2139-2025 FDA Class II initiated 18 Jun 2025 on shared 510(k) K890328

    Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

    • Ongoing Z-0568-2024 FDA Class II initiated 2 Oct 2023

    Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

    • Terminated Z-1952-2018 FDA Class II initiated 17 Apr 2018

    There is a potential for the cord to spark and cause a fire.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
USA Elite
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use
Model / Reference
MLE-28-012
Primary DI / UDI-DI
00821925038486
510(k) Number
FDA Product Code
FAS
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic electrosurgical electrode, monopolar, single-use

Cleared under the same submission (K890328)

Show all (12)

Other devices from Gyrus Acmi, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No