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GSI TympStar Pro Middle Ear Analyzer

by Diagnostic Group, Dba Grason-Stadler 510(k)

Active United States

510(k) K151509

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151509 Date25 Jun 2015ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ETY
Device Class
Class II
Regulation
21 CFR Part 874.1090
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent