← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NQR — Sealant, Dural

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.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
NE
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES

Recent clearances

P130014Stryker Leibinger GmbH & Co KG · pma2026-07-15
P220014Pramand, LLC · pma2026-04-01
P240027Pramand, LLC · pma2026-04-01
P040034Integra LifeSciences Corporation · pma2026-02-27
P080013Integra LifeSciences Corporation · pma2026-02-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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