Cleared Traditional

K942315 - NAVARRE PERCUTANEOUS ACCESS SET

K942315 is an FDA 510(k) clearance for NAVARRE PERCUTANEOUS ACCESS SET, manufactured by Navarre Biomedical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KGZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K942315 · Navarre Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
56d
Days
Class 1
Risk

K942315 is an FDA 510(k) clearance for the NAVARRE PERCUTANEOUS ACCESS SET. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Navarre Biomedical , Ltd. (Hamel, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K942315

510(k) Number K942315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1994
Decision Date July 08, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

KGZ Device Classification - Class 1, General Controls

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.

Regulatory Peers - KGZ Accessories, Catheter

All 14
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K942315.
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CONCEPT SWITCHING STICK
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DESERET UNIVERSAL LUER LOCK
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K821245 · Warner-Lambert Co. · May 1982
PERI-PATCH GLUE MOLD
K810530 · Quinton, Inc. · Mar 1981