Device |
circumcision device with stapler |
Regulation Description |
Obstetric-gynecologic specialized manual instrument. |
Definition |
To cut and suture / staple the prepuce. |
Physical State |
The circumcision device with a stapler is a manual device that includes a circular cutting blade, a ring-type clamp, and a circumferential stapling mechanism. |
Technical Method |
A manual instrument for cutting, clamping, and suturing/stapling the prepuce for the purpose of performing circumcision. |
Target Area |
Penis |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Gastroenterology/Urology |
Product Code | QQR |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.4530
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|