Dilator, Cervical, Hygroscopic-Laminaria
FDA product code HDY · Class II (moderate risk) · 21 CFR 884.4260 · Obstetrics/Gynecology
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040625 | Atad Ard CatheterHDY · Traditional | Atad Developments , Ltd. | 01/18/2005SE |
| K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMHDY · Traditional | Quality Medical Solusions, LLC | 06/25/2002SE |
| K011512 | Mmodification to LaminariaHDY · Traditional | A & A Medical, Inc. | 07/09/2001SE |
| K955072 | LaminariaHDY · Traditional | Cti Corp., Ltd. | 05/22/1996SE |
| K892220 | Laminaria TentHDY · Traditional | Berkeley Medevices | 06/14/1989SE |
| K881295 | Laminaria CurexHDY · Traditional | Harold W. Berger Co. | 08/10/1988SE |
| K881312 | LaminariaHDY · Traditional | Busse Hospital Disposables, Inc. | 05/23/1988SE |
| K880196 | LaminariaHDY · Traditional | Medgyn Products, Inc. | 05/06/1988SE |
| K845006 | Sun Medical Laminaria Cervical DilatorHDY · Traditional | Sun Medical, Inc. | 05/01/1985SE |
| K833068 | Laminaria Japonica Cervical DilatorHDY · Traditional | Medi-Spec | 02/04/1984SE |
| K782067 | Dilator, Mizutani Laminaria TentHDY · Traditional | British Marketing Ent., Ltd. | 01/03/1979SE |