Product code HDY— Obstetrics/Gynecology
LAMINARIA
- Classification name
- Dilator, Cervical, Hygroscopic-Laminaria
- Device class
- Class 2
- Regulation
- 21 CFR 884.4260
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HDY
FDA has cleared devices under product code HDY between 1979 and 2005, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2002
- 2001
- 1996
- 1989
- 1988
- 1985
- 1984
- 1979
Top applicants under product code HDY
Recent clearances under product code HDY
- K040625 — ATAD ARD CATHETER
- K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
- K011512 — MMODIFICATION TO LAMINARIA
- K955072 — LAMINARIA
- K892220 — LAMINARIA TENT
- K881295 — LAMINARIA CUREX
- K881312 — LAMINARIA
- K880196 — LAMINARIA
- K845006 — SUN MEDICAL LAMINARIA CERVICAL DILATOR
- K833068 — LAMINARIA JAPONICA CERVICAL DILATOR
- K782067 — DILATOR, MIZUTANI LAMINARIA TENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.