FDA product code QJA: Tympanostomy Tube Delivery Product With Drug
QJA is the FDA product code for tympanostomy tube delivery product with drug. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under QJA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Classification
| Field | Value |
|---|---|
| Device name | Tympanostomy Tube Delivery Product With Drug |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QJA devices
openFDA lists no recalls for product code QJA.
Frequently asked questions
What is FDA product code QJA?
QJA is the FDA product code for tympanostomy tube delivery product with drug. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is QJA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QJA
- Run a recall and safety report across every QJA manufacturer
- Watch product code QJA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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