Device |
in situ polymerizing peripheral nerve cap |
Definition |
An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma. |
Physical State |
The device is a polymeric, sterile, absorbable, in situ formed, hydrogel cap composed of water and polyethylene glycol. |
Technical Method |
The device is prepared and in situ polymerized at the time of the surgery to form a hydrogel via a chemical reaction. The hydrogel is then delivered around the end of a peripheral nerve within a temporary silicone mold. |
Target Area |
Peripheral Nerves |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | SBG |
Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.5260
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |