Cleared Traditional

K901603 - MODIFIED PORGES SPEC 5* SUPRAPUBIC CATH...

K901603 is the FDA 510(k) clearance for MODIFIED PORGES SPEC 5* SUPRAPUBIC CATH... by Bivona Medical Technologies. It is a Class 2 Gastroenterology & Urology device (product code KOB) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K901603 · Bivona Medical Technologies · Gastroenterology & Urology device
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May 1990
Decision
38d
Days
Class 2
Risk

K901603 is an FDA 510(k) clearance for the MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on May 4, 1990 after a review of 38 days - a notably fast clearance 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: 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 Bivona Medical Technologies devices

Submission Details

510(k) Number K901603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date May 04, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 130d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 7
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K901603.
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · Cook Incorporated · Oct 2018
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · Cook Urological, Inc. · Oct 1986