Cleared Traditional

K881218 - GENT-L-KARE CLEANSING ENEMA SET
(FDA 510(k) Clearance)

K881218 · Geneva Laboratories, Inc. · Gastroenterology & Urology

Jul 1988

Decision

128d

Days

Class 1

Risk

K881218 is an FDA 510(k) clearance for the GENT-L-KARE CLEANSING ENEMA SET. This device is classified as a Enema Kit (Class I — General Controls, product code FCE).

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on July 28, 1988, 128 days after receiving the submission on March 22, 1988.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5210. 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..

Submission Details

510(k) Number	K881218 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1988
Decision Date	July 28, 1988
Days to Decision	128 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.