PFJ · Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Obstetrics/Gynecology · 21 CFR 884.4260 · Class 2
Overview
| Product Code | PFJ |
|---|---|
| Device Name | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Regulation | 21 CFR 884.4260 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143424 | UTAH CVX-RIPE | Utah Medical Products, Inc. | Aug 28, 2015 | SESE |
| K131206 | COOK CERVICAL RIPENING BALLOON | Cook, Inc. | Sep 27, 2013 | SESE |
Top Applicants
- Cook, Inc. — 1 clearance
- Utah Medical Products, Inc. — 1 clearance
