510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180800Unknown

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Colonic Plus, Palm Desert CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180800 is the FDA 510(k) clearance record for Colonic Plus Regular, Small, and Straight Shape Hydrokit, a class II device, cleared for Colonic Plus on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Colonic Plus. As of , FDA records show no recalls naming K180800.

Clearance record

Decision date
Received
(66 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Colonic Plus 73-925 Hwy. 111, Suite L, Palm Desert CA
510(k) summary
Summary PDF
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