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Valleylab E2520H

by Covidien LP

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

25 closed

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 Number10884524000961 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-2559-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2560-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2578-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2555-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2557-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2554-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2563-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2565-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2562-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2556-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2564-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2570-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2568-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2561-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2571-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2576-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2575-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2574-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2569-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2567-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2573-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2566-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2572-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2558-2016 FDA Class II initiated 8 Jul 2016
    • Terminated Z-2577-2016 FDA Class II initiated 8 Jul 2016

    Potential for compromise of the package resulting in a breach of the sterile barrier

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Valleylab
Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Model / Reference
E2520H
Primary DI / UDI-DI
10884524000961
510(k) Number
FDA Product Code
GEI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K926481)

Other devices from Covidien LP

See all devices from Covidien LP →

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