Sealant, Dural

NQR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: NQR
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: NE
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 15

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown