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

Clamp, Circumcision

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

HFX is the FDA product code for Clamp, Circumcision, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
HFX
Device name
Clamp, Circumcision
Regulation
21 CFR 884.4530
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
27
Ingested recalls
14

Clearances, product code HFX

By decision year
27 clearances under product code HFX with a decision year between 1988 and 2026, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HFX by decision year
YearClearances
19881
19892
19901
19944
19951
19972
20011
20043
20051
20072
20101
20122
20131
20152
20221
20231
20261

Applicants with the most clearances

Product code HFX
Applicants holding the most 510(k) clearances under product code HFX
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield2
Thomasville Medical Assoc.2
Centurion Medical Products, LP2
Baxter Healthcare Corporation1
Bionix Development Corp.1
Circ Medtech1
Clinical Innovations, LLC1
Cush Medical Products1
Emergogroup, Inc.1
Fine Surgical Instrument Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order