FDA product code HDY: Dilator, Cervical, Hygroscopic-Laminaria
HDY is the FDA product code for dilator, cervical, hygroscopic-laminaria. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under HDY, from 11 different applicants. The average 510(k) review took 120 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Cervical, Hygroscopic-Laminaria |
| Device class | Class II |
| Regulation | 21 CFR 884.4260 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HDY clearance
Top HDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Atad Developments , Ltd. | 1 | 2005-01-18 |
| Quality Medical Solusions, LLC | 1 | 2002-06-25 |
| A & A Medical, Inc. | 1 | 2001-07-09 |
| Cti Corp., Ltd. | 1 | 1996-05-22 |
| Berkeley Medevices | 1 | 1989-06-14 |
6 more applicants have HDY clearances. See the full list in Caduvo.
Most recent HDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040625 | Atad Developments , Ltd. | ATAD ARD CATHETER | 2005-01-18 | 315 |
| K021012 | Quality Medical Solusions, LLC | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | 2002-06-25 | 88 |
| K011512 | A & A Medical, Inc. | MMODIFICATION TO LAMINARIA | 2001-07-09 | 54 |
| K955072 | Cti Corp., Ltd. | LAMINARIA | 1996-05-22 | 198 |
| K892220 | Berkeley Medevices | LAMINARIA TENT | 1989-06-14 | 72 |
Recalls for HDY devices
openFDA lists no recalls for product code HDY.
Frequently asked questions
What is FDA product code HDY?
HDY is the FDA product code for dilator, cervical, hygroscopic-laminaria. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDY?
Class II, regulation 21 CFR 884.4260. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDY?
Across 11 cleared submissions the average was 120 days from receipt to decision (median 101).
Which companies have the most HDY clearances?
Atad Developments , Ltd. (1); Quality Medical Solusions, LLC (1); A & A Medical, Inc. (1); Cti Corp., Ltd. (1); Berkeley Medevices (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HDY
- Run a recall and safety report across every HDY manufacturer
- Watch product code HDY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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