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N/A 3805-015

by Medtronic PS Medical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 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 Number20643169919789 UDI-DI Date20 Apr 2018ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1110-05 FDA Unclassified (pre-2012) initiated 5 Jul 2005
    • Terminated Z-1111-05 FDA Unclassified (pre-2012) initiated 5 Jul 2005

    Cracked hubs/handles and/or improper peeling of the sheath during use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Wire/ligature passer, reusable
Model / Reference
3805-015
Primary DI / UDI-DI
20643169919789
510(k) Number
FDA Product Code
GWG
GMDN Term
Wire/ligature passer, reusable
Device Class
Class II
Regulation Number
882.1480
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wire/ligature passer, reusable

Cleared under the same submission (K990333)

Other devices from Medtronic PS Medical

See all devices from Medtronic PS Medical →

Properties

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

Other properties (10)

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