Device |
at home intravaginal insemination system |
Regulation Description |
Assisted reproduction catheters. |
Definition |
To deliver semen to the vaginal canal for insemination. |
Physical State |
The device consists of a syringe/catheter with or without a collection cup. |
Technical Method |
A collection cup holds and contains semen or a sperm sample from a donor and works in conjunction with a syringe/catheter which withdraws the semen/sperm sample from the collection cup. The syringe is then used to deliver the semen/sperm sample to the vaginal canal. |
Target Area |
Vaginal canal |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | QYZ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.6110
|
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 |