HYDRO-SAN COLONIC IRRIGATION SYSTEM— 510(k) K891585

Name: FDA 510(k) clearance K891585
Creator: U.S. Food and Drug Administration
Published: 1989-08-03

Substantially Equivalent

Specialty Health Products, Inc.

FDA 510(k) clearance K891585 for HYDRO-SAN COLONIC IRRIGATION SYSTEM, Substantially Equivalent on 1989-08-03. Applicant: Specialty Health Products, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Health Products, Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-20
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPL

view all

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 Specialty Health Products, Inc.

view all

K042234 — MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET2004-09-08

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