SFD — In Situ Polymerizing Peripheral Nerve Repair Device Class II
FDA product code SFD covers "In Situ Polymerizing Peripheral Nerve Repair Device", a Class II medical device regulated under 21 CFR 882.5270. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SFD
- Device Class
- Class II
- Regulation Number
- 882.5270
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.