K252436
- 510(k) number
- K252436
- Device name
- Tula Tympanostomy Tube Delivery Device
- Applicant
- Tusker Medical, Inc. TX · US
- Product code
- ETD — Tube, Tympanostomy
- Decision date
- 2026-04-23
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252436.pdf
Official FDA record: K252436
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.