Cleared Traditional

K901179 - ENEMA BUCKET SET
(FDA 510(k) Clearance)

K901179 · Orion Life Systems, Inc. · Gastroenterology & Urology

Jun 1990

Decision

107d

Days

Class 1

Risk

K901179 is an FDA 510(k) clearance for the ENEMA BUCKET SET, a Enema Kit (Class I — General Controls, product code FCE), submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 28, 1990, 107 days after receiving the submission on March 13, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5210.

Submission Details

510(k) Number	K901179 FDA.gov
FDA Decision	Cleared SESK
Date Received	March 13, 1990
Decision Date	June 28, 1990
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	FCE — Enema Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 876.5210
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.