Cleared Traditional

K943663 - NAVARRE 600 ML DRAINAGE BAG

K943663 is an FDA 510(k) clearance for NAVARRE 600 ML DRAINAGE BAG, manufactured by Navarre Biomedical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EXF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K943663 · Navarre Biomedical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
42d
Days
Class 2
Risk

K943663 is an FDA 510(k) clearance for the NAVARRE 600 ML DRAINAGE BAG. Classified as Bag, Bile Collecting (product code EXF), Class II - Special Controls.

Submitted by Navarre Biomedical , Ltd. (Plymouth, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K943663

510(k) Number K943663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date September 08, 1994
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXF Device Classification - Class 2, Special Controls

Product Code EXF Bag, Bile Collecting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - EXF Bag, Bile Collecting

Devices cleared under the same product code (EXF) and FDA review panel - the closest regulatory comparables to K943663.
MANAN D BAG
K980005 · Medical Device Technologies, Inc. · Jan 1998
MANAN D BAG
K961986 · Manan Medical Products, Inc. · Mar 1997
MANAN D BAG
K963849 · Manan Medical Products, Inc. · Dec 1996
URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET
K903449 · Uresil Corp. · Sep 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844 · Uresil Corp. · Jun 1990