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

Dilator, Cervical, Fixed Size

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDQ is the FDA product code for Dilator, Cervical, Fixed Size, a class I device type, regulated under 21 CFR 884.4530. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HDQ
Device name
Dilator, Cervical, Fixed Size
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
4

Clearances, product code HDQ

By decision year
6 clearances under product code HDQ with a decision year between 1979 and 1994, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HDQ by decision year
YearClearances
19791
19811
19892
19901
19941

Applicants with the most clearances

Product code HDQ
Applicants holding the most 510(k) clearances under product code HDQ
ApplicantClearances
Cavitron Corp.1
Cook Ob/Gyn1
Gynemetrics, Inc.1
Kinetic Medical Products1
Thomasville Medical Assoc.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 146 companies shown, in name order