Cleared Traditional

4 SURE TM ENEMA BAG SET

K922398 · Boston Pacific Medical, Inc. · Gastroenterology & Urology

Jun 1993

Decision

392d

Days

Class 1

Risk

About This 510(k) Submission

K922398 is an FDA 510(k) clearance for the 4 SURE TM ENEMA BAG SET, a Enema Kit (Class I — General Controls, product code FCE), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on June 17, 1993, 392 days after receiving the submission on May 21, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5210.

Submission Details

510(k) Number	K922398 FDA.gov
FDA Decision	Cleared SEKD
Date Received	May 21, 1992
Decision Date	June 17, 1993
Days to Decision	392 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

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.