Device |
culture, intravaginal, assisted reproduction |
Regulation Description |
Intravaginal culture system. |
Definition |
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period. |
Physical State |
Polymeric culture device. |
Technical Method |
Culture device designed to hold and maintain gametes and embryos during intravaginal culture procedures. |
Target Area |
Gametes and embryos |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | OYO |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.6165
|
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 |