510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HDYClass II

Dilator, Cervical, Hygroscopic-Laminaria

21 CFR 884.4260 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDY is the FDA product code for Dilator, Cervical, Hygroscopic-Laminaria, a class II device type, regulated under 21 CFR 884.4260. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HDY
Device name
Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
0

Clearances, product code HDY

By decision year
11 clearances under product code HDY with a decision year between 1979 and 2005, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HDY by decision year
YearClearances
19791
19841
19851
19883
19891
19961
20011
20021
20051

Applicants with the most clearances

Product code HDY
Applicants holding the most 510(k) clearances under product code HDY
ApplicantClearances
A & A Medical, Inc.1
Atad Developments, Ltd.1
Berkeley Medevices1
British Marketing Ent., Ltd.1
Busse Hospital Disposables1
Cti Corp., Ltd.1
Harold W. Berger Co.1
Medgyn Products, Inc.1
Medi-Spec1
Quality Medical Solusions, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code