Last synced on 27 January 2023 at 11:04 pm

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4260
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.4260 Hygroscopic Laminaria cervical dilator

§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a) Identification. A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.

(b) Classification. Class II (performance standards).

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4260
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.4260 Hygroscopic Laminaria cervical dilator

§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a) Identification. A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.

(b) Classification. Class II (performance standards).