Tula® System
FDA premarket approval P190016 · decided 2019-11-25
Approval details
- PMA number
- P190016
- Trade name
- Tula® System
- Generic name
- Tympanostomy tube delivery product with drug
- Applicant
- Tusker Medical, Inc.
- Date received
- 2019-05-31
- Decision date
- 2019-11-25
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QJA
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for the Tula® System. This device is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist.TYMBION, a combination of an amide
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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 |