FDA product code NQR: Sealant, Dural
NQR is the FDA product code for sealant, dural. It is a Class III device, reviewed by the Neurology panel. Devices under NQR reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code.
Definition
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Classification
| Field | Value |
|---|---|
| Device name | Sealant, Dural |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NQR devices
openFDA lists no recalls for product code NQR.
Frequently asked questions
What is FDA product code NQR?
NQR is the FDA product code for sealant, dural. It is a Class III device, reviewed by the Neurology panel.
What device class is NQR?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NQR
- Run a recall and safety report across every NQR manufacturer
- Watch product code NQR 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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