HDY · Dilator, Cervical, Hygroscopic-Laminaria
Obstetrics/Gynecology · 21 CFR 884.4260 · Class 2
Overview
| Product Code | HDY |
|---|---|
| Device Name | Dilator, Cervical, Hygroscopic-Laminaria |
| 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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040625 | ATAD ARD CATHETER | Atad Developments , Ltd. | Jan 18, 2005 | SESE |
| K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | Jun 25, 2002 | SESE |
| K011512 | MMODIFICATION TO LAMINARIA | A & A Medical, Inc. | Jul 9, 2001 | SESE |
| K955072 | LAMINARIA | Cti Corp., Ltd. | May 22, 1996 | SESE |
| K892220 | LAMINARIA TENT | Berkeley Medevices | Jun 14, 1989 | SESE |
| K881295 | LAMINARIA CUREX | Harold W. Berger Co. | Aug 10, 1988 | SESE |
| K881312 | LAMINARIA | Busse Hospital Disposables, Inc. | May 23, 1988 | SESE |
| K880196 | LAMINARIA | Medgyn Products, Inc. | May 6, 1988 | SESE |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | May 1, 1985 | SESE |
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Medi-Spec | Feb 4, 1984 | SESE |
| K782067 | DILATOR, MIZUTANI LAMINARIA TENT | British Marketing Ent., Ltd. | Jan 3, 1979 | SESE |
Top Applicants
- A & A Medical, Inc. — 1 clearance
- Atad Developments , Ltd. — 1 clearance
- Berkeley Medevices — 1 clearance
- British Marketing Ent., Ltd. — 1 clearance
- Busse Hospital Disposables, Inc. — 1 clearance
