Cleared Traditional

K932021 - ENTREE CANNULA FASCIA ANCHORS

K932021 is an FDA 510(k) clearance for ENTREE CANNULA FASCIA ANCHORS, manufactured by Core Dynamics, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FBM cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K932021 · Core Dynamics, Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
263d
Days
Class 1
Risk

K932021 is an FDA 510(k) clearance for the ENTREE CANNULA FASCIA ANCHORS. 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 January 11, 1994 after a review of 263 days - an extended review 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: 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 Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K932021

510(k) Number K932021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date January 11, 1994
Days to Decision 263 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
133d slower than avg
Panel avg: 130d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

FBM Device Classification - Class 1, General Controls

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.