Cleared Traditional

K880337 - MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K880337 · Plasco, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
79d
Days
Class 1
Risk

K880337 is an FDA 510(k) clearance for the MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700. Classified as Enema Kit (product code FCE), Class I - General Controls.

Submitted by Plasco, Inc. (Gurnee, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5210 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Plasco, Inc. devices

Submission Details

510(k) Number K880337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date April 14, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCE Enema Kit
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.