Product code HDY
- Device name
- Dilator, Cervical, Hygroscopic-Laminaria
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4260
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040625 | ATAD ARD CATHETER | Atad Developments , Ltd. | 2005-01-18 |
| K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002-06-25 |
| K011512 | MMODIFICATION TO LAMINARIA | A & A Medical, Inc. | 2001-07-09 |
| K955072 | LAMINARIA | Cti Corp., Ltd. | 1996-05-22 |
| K892220 | LAMINARIA TENT | Berkeley Medevices | 1989-06-14 |
| K881295 | LAMINARIA CUREX | Harold W. Berger Co. | 1988-08-10 |
| K881312 | LAMINARIA | Busse Hospital Disposables, Inc. | 1988-05-23 |
| K880196 | LAMINARIA | Medgyn Products, Inc. | 1988-05-06 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | 1985-05-01 |
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Medi-Spec | 1984-02-04 |
| K782067 | DILATOR, MIZUTANI LAMINARIA TENT | British Marketing Ent., Ltd. | 1979-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974213565783 | Malibu | WENZHOU TIDE-OPTICAL CO.,LTD | 2026-04-13 |
| GYNX161051 | Laminaria | GYNEX CORPORATION | 2017-01-19 |
| GYNX161041 | Laminaria | GYNEX CORPORATION | 2017-01-19 |
| GYNX161031 | Laminaria | GYNEX CORPORATION | 2017-01-19 |
| 60888937003330 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 60888937003323 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 60888937003316 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 60888937003309 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 00888937003338 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 00888937003321 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 00888937003314 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| 00888937003307 | Dilateria | Coopersurgical, Inc. | 2016-09-20 |
| M803021025 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021026 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021002 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021024 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021023 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021022 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021018 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021016 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021015 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021014 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021010 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021008 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021006 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021005 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021004 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |
| M803021003 | MedGyn Laminaria | MEDGYN PRODUCTS, INC. | 2016-08-29 |