Cleared Traditional

ENTREE CANNULA (K911813) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K911813 · Core Dynamics, Inc. · Gastroenterology & Urology device
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Jul 1991
Decision
87d
Days
Class 1
Risk

K911813 is an FDA 510(k) clearance for the ENTREE CANNULA. Classified as Cannula And Trocar, Suprapubic, Non-disposable (product code FBM), Class I - General Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Core Dynamics, Inc. devices

Submission Details

510(k) Number K911813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1991
Decision Date July 19, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FBM Cannula And Trocar, Suprapubic, Non-disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5090
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.