Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
The Balloon Catheter for Dilation of the Cervical Canal Prior to Labor is an obstetrics/gynecology device used to mechanically dilate the cervical canal to induce or facilitate labor, providing a non-pharmacological approach to cervical ripening and labor induction. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.4260, requiring 510(k) premarket notification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PFJ
- Device Class
- FDA class 2
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Mechanical dilation of the cervical canal for labor.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.