Last synced on 27 January 2023 at 11:04 pm

Catheter, Balloon, Dilation Of Cervical Canal

Page Type
Product Code
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
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

Page Type
Product Code
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
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).