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

Mold, Vaginal

21 CFR 884.3900 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFK is the FDA product code for Mold, Vaginal, a class II device type, regulated under 21 CFR 884.3900. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HFK
Device name
Mold, Vaginal
Regulation
21 CFR 884.3900
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
1
Ingested recalls
0

Clearances, product code HFK

By decision year
1 clearance under product code HFK with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HFK by decision year
YearClearances
19931

Applicants with the most clearances

Product code HFK
Applicants holding the most 510(k) clearances under product code HFK
ApplicantClearances
Medsurg Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HFK.