GC IRRIGATOR— 510(k) K980868

Substantially Equivalent

Gentle Colonics, Inc.

FDA 510(k) clearance K980868 for GC IRRIGATOR, Substantially Equivalent on 1998-08-06. Applicant: Gentle Colonics, Inc.. Device class: 2.

Clearance details

Applicant: Gentle Colonics, Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1998-03-06
Decision date: 1998-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPL

K201861 — Bio Fluff System2022-03-02
K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit2018-06-01
K152834 — Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 102016-08-10
K150381 — AQUA CLEANSE2015-09-11
K131852 — HC-1 AND HC-1 CLASSIC2014-04-17

More clearances from Gentle Colonics, Inc.

K002102 — GENTLE COLONICS IRRIGATION SYSTEM2002-02-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.