Laminaria Japonica Cervical Dilator
FDA 510(k) K833068 · Medi-Spec
510(k) numberK833068
Submission
- Device name
- Laminaria Japonica Cervical Dilator
- Applicant
- Medi-Spec
Mchenry, IL, US - Received
- September 8, 1983
- Decision date
- February 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDY – Dilator, Cervical, Hygroscopic-Laminaria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDY
| 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 |
| K782067 | Dilator, Mizutani Laminaria TentHDY · Traditional | British Marketing Ent., Ltd. | 01/03/1979SE |
More from British Marketing Ent., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K812694 | Whisk-RGEE · Traditional | 10/26/1981SE |
| K812426 | Uterine Aspiration Curettes(Rigid&Flex)HHK · Traditional | 10/08/1981SE |
| K801554 | Sterile Cast PaddingHIX · Traditional | 08/04/1980SE |
| K800404 | Medspec Operative Opthalmic KitHMP · Traditional | 04/24/1980SE |
| K800490 | Sterile Dressing PackKKX · Traditional | 03/12/1980SE |
| K790952 | Clamp CoversGAD · Traditional | 06/05/1979SE |
| K780548 | Disposa-LoopsKKX · Traditional | 08/21/1978SE |
Questions and answers
When was Laminaria Japonica Cervical Dilator cleared by the FDA?
Laminaria Japonica Cervical Dilator (K833068) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 149 days after the submission was received.
What is the product code of K833068?
The FDA product code is HDY – Dilator, Cervical, Hygroscopic-Laminaria, a Class II (moderate risk) device regulated under 21 CFR 884.4260.