510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863539Substantially Equivalent

Hydro-Clenz Unit

Atlantic Health Group, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863539 is the FDA 510(k) clearance record for HYDRO-CLENZ UNIT, a class II device, cleared for Atlantic Health Group on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Atlantic Health Group. As of , FDA records show no recalls naming K863539.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Atlantic Health Group 6400 Atlantic Blvd., Suite, Norcross GA
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

FDA records show no clearances under product code KPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPL, 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