HDY — Dilator, Cervical, Hygroscopic-Laminaria Class II
FDA product code HDY covers "Dilator, Cervical, Hygroscopic-Laminaria", a Class II medical device regulated under 21 CFR 884.4260. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HDY
- Device Class
- Class II
- Regulation Number
- 884.4260
- Submission Type
- 510(k)
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040625 | Atad Developments | ATAD ARD CATHETER | Jan 18, 2005 |
| K021012 | Quality Medical Solusions | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Jun 25, 2002 |
| K011512 | A And A Medical | MMODIFICATION TO LAMINARIA | Jul 9, 2001 |
| K955072 | Cti Corp | LAMINARIA | May 22, 1996 |
| K892220 | Berkeley Medevices | LAMINARIA TENT | Jun 14, 1989 |
| K881295 | Harold W. Berger | LAMINARIA CUREX | Aug 10, 1988 |
| K881312 | Busse Hospital Disposables | LAMINARIA | May 23, 1988 |
| K880196 | Medgyn Products | LAMINARIA | May 6, 1988 |
| K845006 | Sun Medical | SUN MEDICAL LAMINARIA CERVICAL DILATOR | May 1, 1985 |
| K833068 | Medi-Spec | LAMINARIA JAPONICA CERVICAL DILATOR | Feb 4, 1984 |
| K782067 | British Marketing Ent | DILATOR, MIZUTANI LAMINARIA TENT | Jan 3, 1979 |