Product code QJA
- Device name
- Tympanostomy Tube Delivery Product With Drug
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P190016S012 | Tula® System | Tusker Medical, Inc. | 2026-07-31 |
| P190016S011 | Tula Tube Delivery System (TDS) | Tusker Medical, Inc. | 2026-01-21 |
| P190016S010 | Tula® System | Tusker Medical, Inc. | 2025-10-24 |
| P190016S009 | Tula® System | Tusker Medical, Inc. | 2025-01-31 |
| P190016S007 | Tula® System | Tusker Medical, Inc. | 2024-02-01 |
| P190016S008 | Tula System | Tusker Medical, Inc. | 2023-12-22 |
| P190016S006 | Tula® System | Tusker Medical, Inc. | 2022-12-15 |
| P190016S005 | Tula® System | Tusker Medical, Inc. | 2022-09-22 |
| P190016S003 | Tula System | Tusker Medical, Inc. | 2021-09-08 |
| P190016S002 | Tula System | Tusker Medical, Inc. | 2020-12-30 |
| P190016S001 | Tula SystemTube Delivery System (TDS) | Tusker Medical, Inc. | 2020-05-06 |
| P190016 | Tula® System | Tusker Medical, Inc. | 2019-11-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556817667 | TULA | Smith & Nephew, Inc. | 2024-04-29 |
| 00885556817759 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817739 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817722 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817715 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817708 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817692 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20885556817685 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817797 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817780 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817773 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817766 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817742 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 00885556817674 | TULA | Smith & Nephew, Inc. | 2024-04-23 |
| 20840128600096 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600023 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600030 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600047 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 20840128600058 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 20840128600072 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 20840128600089 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600054 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600016 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600207 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600122 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600115 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600108 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600092 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600085 | TULA | Smith & Nephew, Inc. | 2020-03-25 |
| 00840128600078 | TULA | Smith & Nephew, Inc. | 2020-03-25 |