Device |
septal stapler/absorbable staples |
Regulation Description |
Implantable staple. |
Definition |
To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction. |
Physical State |
Resorbable polymer (e.g., poly(L-lactide-co-glycolide) with a size of approximately 5 mm X 2.5 mm X 0.5 mm thick. |
Technical Method |
Resorbable fixation devices are delivered via a pre-loaded manual surgical stapler delivery system. |
Target Area |
Nasal septum. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Ear Nose & Throat |
Product Code | OLL |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
878.4750
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |