510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980868Substantially Equivalent

Gc Irrigator

Gentle Colonics, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980868 is the FDA 510(k) clearance record for GC IRRIGATOR, a class II device, cleared for Gentle Colonics, Inc. on under FDA product code KPL (Colonic Irrigation System). FDA records list 2 510(k) clearances for Gentle Colonics, Inc., from to . As of , FDA records show no recalls naming K980868.

Clearance record

Decision date
Received
(153 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gentle Colonics, Inc. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
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