Device |
catheter, balloon, dilation of cervical canal prior to labor |
Regulation Description |
Hygroscopic Laminaria cervical dilator. |
Definition |
Mechanical dilation of the cervical canal for labor. |
Physical State |
Catheter with inflatable balloon |
Technical Method |
Use mechanical force to dilate cervix to prepare for vaginal delivery. |
Target Area |
Uterine cervix |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | PFJ |
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
|