Cleared Traditional

SHUFFIELD TECH ENEMA TIP (K832960) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K832960 · Shuffield Tech Co. · Gastroenterology & Urology device
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Jan 1984
Decision
126d
Days
Class 1
Risk

K832960 is an FDA 510(k) clearance for the SHUFFIELD TECH ENEMA TIP. Classified as Enema Kit (product code FCE), Class I - General Controls.

Submitted by Shuffield Tech Co. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shuffield Tech Co. devices

Submission Details

510(k) Number K832960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1983
Decision Date January 03, 1984
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
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.