Cleared Traditional

K932391 - NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE C...

K932391 is an FDA 510(k) clearance for NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE C..., manufactured by Navarre Biomedical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K932391 · Navarre Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
254d
Days
Class 1
Risk

K932391 is an FDA 510(k) clearance for the NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Navarre Biomedical , Ltd. (Hamel, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K932391

510(k) Number K932391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date January 27, 1994
Days to Decision 254 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
139d slower than avg
Panel avg: 115d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
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 - GBX Catheter, Irrigation

All 34
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K932391.
STORZ N5941 SERIES MEDICAL GRADE TUBING
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ERCP CATHETER, HYDROPHILIC COATED
K932205 · Wilson-Cook Medical, Inc. · Jan 1994
URESIL ABSCESS DRIANAGE AND IRRIGATION SET
K925117 · Uresil Corp. · Aug 1993
FLUID DRAINAGE TRAY
K926109 · Symbiosis Corp. · Jun 1993