Device |
catheter, balloon, dilation of cervical canal |
Regulation Description |
Hygroscopic Laminaria cervical dilator. |
Definition |
Mechanical dilation and softening of the cervix. |
Physical State |
Catheter with inflatable balloons. |
Technical Method |
When placed in the cervical canal, the device uses mechanical force to dilate and soften the cervix. |
Target Area |
Cervical canal |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | PON |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.4260
|
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
|
Accredited Persons
|