Dilator, Cervical, Hygroscopic-Laminaria
The Hygroscopic-Laminaria Cervical Dilator is a natural or synthetic cervical dilator that absorbs moisture and gradually expands to dilate the cervical os over several hours, commonly used prior to surgical procedures or second-trimester procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HDY, regulated under 21 CFR 884.4260, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HDY
- Device Class
- FDA class 2
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040625 | ATAD ARD CATHETER | Jan 18, 2005 | Substantially Equivalent | Atad Developments , Ltd. |
| K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Jun 25, 2002 | Substantially Equivalent | Quality Medical Solusions, LLC |
| K011512 | MMODIFICATION TO LAMINARIA | Jul 09, 2001 | Substantially Equivalent | A & A Medical, Inc. |
| K955072 | LAMINARIA | May 22, 1996 | Substantially Equivalent | Cti Corp., Ltd. |
| K892220 | LAMINARIA TENT | Jun 14, 1989 | Substantially Equivalent | Berkeley Medevices |
| K881295 | LAMINARIA CUREX | Aug 10, 1988 | Substantially Equivalent | Harold W. Berger Co. |
| K881312 | LAMINARIA | May 23, 1988 | Substantially Equivalent | Busse Hospital Disposables, Inc. |
| K880196 | LAMINARIA | May 06, 1988 | Substantially Equivalent | Medgyn Products, Inc. |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | May 01, 1985 | Substantially Equivalent | Sun Medical, Inc. |
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Feb 04, 1984 | Substantially Equivalent | Medi-Spec |
| K782067 | DILATOR, MIZUTANI LAMINARIA TENT | Jan 03, 1979 | Substantially Equivalent | British Marketing Ent., Ltd. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.