In Situ Polymerizing Peripheral Nerve Repair Device
An in situ polymerizing peripheral nerve repair device is a neurological implant device intended for the sutureless repair of peripheral nerve injuries, using precursor materials that polymerize in situ to bridge and support nerve repair without the need for sutures, potentially simplifying the surgical repair of damaged peripheral nerves. It is classified as FDA Class II (510(k) required) under regulation 882.5270 in the Neurology specialty, with product code SFD. The device is flagged as an implant, reflecting its permanent in vivo placement, but does not support life-sustaining functions.
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Basic Information
- Product Code
- SFD
- Device Class
- FDA class 2
- Regulation Number
- 882.5270
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.