| Device |
in situ polymerizing peripheral nerve repair device |
| Definition |
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries. |
| Physical State |
The device consists of a polymeric, sterile, absorbable, component which is polymerized in situ using an externally applied process, energy source, or chemical. |
| Technical Method |
The device is prepared, placed at the target nerve repair location, and polymerized in situ at the time of the surgery. Polymerization is initiated using an externally applied process, energy source, or chemical to form a crosslinked polymer at and/or around the injured peripheral nerve. |
| Target Area |
Peripheral Nerves |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SFD |
|---|
| Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5270
|
|---|
| 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 |
|
|
