Tula Tympanostomy Tube Delivery Device— 510(k) K252436
Substantially EquivalentTusker Medical, Inc.
FDA 510(k) clearance K252436 for Tula Tympanostomy Tube Delivery Device, Substantially Equivalent on 2026-04-23. Applicant: Tusker Medical, Inc.. Device class: 2.
Summary
Tusker Medical's Tula Tympanostomy Tube Delivery Device is filed under product code ETD (Tube, Tympanostomy).
Class II, 21 CFR 874.3880. Ear, Nose, and Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tusker Medical filed from Austin, Texas. The decision came 265 calendar days after FDA received it (August 1, 2025 to April 23, 2026).
Clearance details
- Applicant
- Tusker Medical, Inc.
- Product code
- Product code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code ETD
view all- K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
- K221254 — Hummingbird Tympanostomy Tube System
Data sourced from openFDA. This site is unofficial and independent of the FDA.