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Ear Coupler TR 101506

by PATH medical GmbH Germany GUDID

Product code GWJ

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260223147746 UDI-DIDate24 Jul 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0403-2024 FDA Class II initiated 26 Sep 2023 via K133012, on the same 510(k)
    • Ongoing Z-0401-2024 FDA Class II initiated 26 Sep 2023 via K133012, on the same 510(k)
    • Ongoing Z-0404-2024 FDA Class II initiated 26 Sep 2023 via K133012, on the same 510(k)
    • Ongoing Z-0402-2024 FDA Class II initiated 26 Sep 2023 via K133012, on the same 510(k)

    Affected lots of product may experience technical distortions to a greater extent than expected.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Ear Coupler TR
Generic Name
Evoked-potential audiometer
Model / Reference
101506
Primary DI / UDI-DI
04260223147746
510(k) Number
FDA Product Code
GWJ
GMDN Term
Evoked-potential audiometer
Device Class
Class II
Regulation Number
882.1900
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K133012)

Show all (12)

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI 0302b141-a954-4d52-81fa-c0706718026c 34 fields · synced 23 Oct 2026