Sealant, Dural
The dural sealant is a neurosurgical implant device sprayed or layered onto sutured dural wound edges to polymerize in place and prevent cerebrospinal fluid leakage through suture-approximated dural incisions following brain or spinal surgery. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) given the critical and life-sustaining function of the dura. Product code NQR carries both implant and life-sustaining flags and is reviewed by the Neurology panel.
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Basic Information
- Product Code
- NQR
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.