Tula Tympanostomy Tube Delivery Device— 510(k) K252436

Substantially Equivalent

Tusker Medical, Inc.

FDA 510(k) clearance K252436 for Tula Tympanostomy Tube Delivery Device, Substantially Equivalent on 2026-04-23. Applicant: Tusker Medical, Inc..

Clearance details

Applicant: Tusker Medical, Inc.
Product code: Code ETD
Advisory panel: Ear, Nose, Throat
Date received: 2025-08-01
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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