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

Brush, Endometrial

21 CFR 884.1100 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFE is the FDA product code for Brush, Endometrial, a class II device type, regulated under 21 CFR 884.1100. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HFE
Device name
Brush, Endometrial
Regulation
21 CFR 884.1100
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
9
Ingested recalls
1

Clearances, product code HFE

By decision year
9 clearances under product code HFE with a decision year between 1985 and 2024, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HFE by decision year
YearClearances
19851
19881
19901
19941
19951
20081
20121
20171
20241

Applicants with the most clearances

Product code HFE
Applicants holding the most 510(k) clearances under product code HFE
ApplicantClearances
Cook Incorporated2
Cook Ob/Gyn2
Gyneco, Inc.1
Intl. Cytobrush, Inc.1
Laboratoire Ccd C/O Washington Regulatory Services1
Post Oak Innovations, Inc.1
Utepreva, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code