HDY
11 FDA 510(k) clearances · Product code
101 daysmedian time to decision
198 days90th percentile
11clearances measured
FDA profile
- Official device name
- Dilator, Cervical, Hygroscopic-Laminaria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 1 · 2003: 2 · 2005: 2 · 2007: 2 · 2008: 3 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ATAD ARD CATHETER (K040625) | Atad Developments , Ltd. | 2005-01-18 |
| LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (K021012) | Quality Medical Solusions, LLC | 2002-06-25 |
| MMODIFICATION TO LAMINARIA (K011512) | A & A Medical, Inc. | 2001-07-09 |
| LAMINARIA (K955072) | Cti Corp., Ltd. | 1996-05-22 |
| LAMINARIA TENT (K892220) | Berkeley Medevices | 1989-06-14 |
| LAMINARIA CUREX (K881295) | Harold W. Berger Co. | 1988-08-10 |
| LAMINARIA (K881312) | Busse Hospital Disposables, Inc. | 1988-05-23 |
| LAMINARIA (K880196) | Medgyn Products, Inc. | 1988-05-06 |
| SUN MEDICAL LAMINARIA CERVICAL DILATOR (K845006) | Sun Medical, Inc. | 1985-05-01 |
| LAMINARIA JAPONICA CERVICAL DILATOR (K833068) | Medi-Spec | 1984-02-04 |
| DILATOR, MIZUTANI LAMINARIA TENT (K782067) | British Marketing Ent., Ltd. | 1979-01-03 |
Track HDY automatically
Every clearance here is in the API, with alerts when new ones post.