PKN · Dilator, Cervical, Synthetic, Osmotic
Obstetrics/Gynecology · 21 CFR 884.4260 · Class 2
Overview
| Product Code | PKN |
|---|---|
| Device Name | Dilator, Cervical, Synthetic, Osmotic |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143447 | Dilapan-S | Medicem Technology S.R.O | Apr 17, 2015 | SESE |
Top Applicants
- Medicem Technology S.R.O — 1 clearance
