510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855150Substantially Equivalent

Hpk-a Device Dfor the Treatment of Hemorrhoids

Hpk International, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855150 is the FDA 510(k) clearance record for HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS, cleared for Hpk International, Inc. on under FDA product code LKX (Device, Thermal, Hemorrhoids). FDA records list one 510(k) clearance for Hpk International, Inc. As of , FDA records show no recalls naming K855150.

Clearance record

Decision date
Received
(96 days to decision)
Product code
LKX Device, Thermal, Hemorrhoids
Device class
Unclassified
Review panel
Unknown
Applicant
Hpk International, Inc. 600 New Hampshire Ave., NW,, Washington DC
Third party review
No

Clearances, product code LKX

Trailing 12 months

FDA records hold no clearances under product code LKX in the trailing twelve months.

FDA records show no clearances under product code LKX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260