Tula SystemTube Delivery System (TDS)
FDA premarket approval P190016/S001 · decided 2020-05-06
Approval details
- PMA number
- P190016
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tula SystemTube Delivery System (TDS)
- Generic name
- Tympanostomy tube delivery product with drug
- Applicant
- Tusker Medical, Inc.
- Date received
- 2020-04-09
- Decision date
- 2020-05-06
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QJA
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Modification to the receiving inspection test method for the Barrel Cam, a component of the Tula Tube Delivery System.
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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 |