Cleared Traditional

K933109 - 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS

K933109 is the FDA 510(k) clearance for 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS by Boston Pacific Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K933109 · Boston Pacific Medical, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
276d
Days
Class 2
Risk

K933109 is an FDA 510(k) clearance for the 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 276 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Boston Pacific Medical, Inc. devices

Submission Details

510(k) Number K933109 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 25, 1993
Decision Date March 28, 1994
Days to Decision 276 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
146d slower than avg
Panel avg: 130d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 69
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K933109.
IMAGER TORQUE CATHETER
K965229 · Boston Scientific Corp · Mar 1997
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K951260 · Biosearch Medical Products, Inc. · Sep 1995
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · Cook Urological, Inc. · Dec 1993
ONIK-COHEN ACCESS SET
K930608 · Cook Urological, Inc. · Jul 1993
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993