PON · Catheter, Balloon, Dilation Of Cervical Canal
Obstetrics/Gynecology · 21 CFR 884.4260 · Class 2
Overview
| Product Code | PON |
|---|---|
| Device Name | Catheter, Balloon, Dilation Of Cervical Canal |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | Oct 15, 2021 | SESE |
| K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | Nov 6, 2020 | SESE |
| K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | Aug 23, 2019 | SESE |
| K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | Aug 1, 2016 | SESE |
Top Applicants
- Gtimd, LLC — 3 clearances
- Crossbay Medical — 1 clearance
