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

Device, Thermal, Hemorrhoids

Unknown
FDA source (opens on fda.gov)

LKX is the FDA product code for Device, Thermal, Hemorrhoids. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKX
Device name
Device, Thermal, Hemorrhoids
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
0

Clearances, product code LKX

By decision year
18 clearances under product code LKX with a decision year between 1981 and 2018, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LKX by decision year
YearClearances
19811
19822
19851
19863
19881
19911
19921
19951
19982
20011
20051
20081
20121
20181

Applicants with the most clearances

Product code LKX
Applicants holding the most 510(k) clearances under product code LKX
ApplicantClearances
J. & Jp., Inc.2
A.Stein - Regulatory Affairs Consulting1
American Pharmaceutical Co., Inc.1
Behive, Ltd.1
Bio-Dyne, Inc.1
Cryoptherapy Pain Relief Products, Inc.1
Cryotherapy Products, Inc.1
Dunmore Corp.1
Fama Holdings International Corp1
Hpk International, 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 LKX.