Cleared Traditional

K190327 - ENConnect 40 mm Screw Cap to ENPlus Adapter (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190327 · Cedic S.R.L. · Gastroenterology & Urology device
Apr 2019
Decision
55d
Days
Class 2
Risk

K190327 is an FDA 510(k) clearance for the ENConnect 40 mm Screw Cap to ENPlus Adapter. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on April 9, 2019 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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.

Submission Details

510(k) Number K190327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date April 09, 2019
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 156d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

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