Device |
cannula, injector, uterine, endometrial biopsy |
Regulation Description |
Obstetric-gynecologic specialized manual instrument. |
Definition |
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy |
Physical State |
cannula that allows injection of saline and/or contrast media and component that collects an endometrial biopsy sample |
Technical Method |
inserted manually through the vagina and cervix and into the uterus; delivers saline and/or contrast media into the uterus and fallopian tubes, collects endometrial biopsy sample |
Target Area |
uterus, fallopian tubes |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | PGK |
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 |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|