Tula® System
FDA premarket approval P190016/S009 · decided 2025-01-31
Approval details
- PMA number
- P190016
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tula® System
- Generic name
- Tympanostomy tube delivery product with drug
- Applicant
- Tusker Medical, Inc.
- Date received
- 2024-08-07
- Decision date
- 2025-01-31
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- QJA
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- approval for a manufacturing site located at, RxCrossroads (Clermont Site)170 Clermont RoadSuite AShepherdsville, KY 40165;which performs the final kitting of the Tula System Drug Pack and logistics distribution of the Tula System (Tula Kit, Drug Pack, and spares) to customers, on behalf of Tusker Medical.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Tula Tympanostomy Tube Delivery Device (K252436) | Tusker Medical, Inc. | 2026-04-23 |