← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

SFD — In Situ Polymerizing Peripheral Nerve Repair Device

An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5270
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K251957Tissium SA · 510k2025-09-08
DEN240066Tissium SA · 510k2025-06-17

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →