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

Curette, Uterine

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

HCY is the FDA product code for Curette, Uterine, a class I device type, regulated under 21 CFR 884.4530. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HCY
Device name
Curette, Uterine
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
11
Ingested recalls
1

Clearances, product code HCY

By decision year
11 clearances under product code HCY with a decision year between 1979 and 1998, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HCY by decision year
YearClearances
19791
19811
19841
19851
19861
19881
19891
19901
19941
19951
19981

Applicants with the most clearances

Product code HCY
Applicants holding the most 510(k) clearances under product code HCY
ApplicantClearances
Baxter Healthcare Corporation1
British Marketing Ent., Ltd.1
D.L. Nelson and Assoc., Inc.1
Gynemetrics, Inc.1
Imagyn Medical Technologies, Inc.1
Ivory Instruments Co.1
Kinetic Medical Products1
Luneau Laboratories1
Nu-Gyn-Tek, Inc.1
Phase I Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 124 companies shown, in name order