Cleared Traditional

K896426 - PORGES SPHINCTEROTOMES

K896426 is an FDA 510(k) clearance for PORGES SPHINCTEROTOMES, manufactured by Porges Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K896426 · Porges Corp. · Gastroenterology & Urology device
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Jan 1990
Decision
75d
Days
Class 2
Risk

K896426 is an FDA 510(k) clearance for the PORGES SPHINCTEROTOMES. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Porges Corp. (Gary, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Porges Corp. devices

FDA 510(k) Submission Details - K896426

510(k) Number K896426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1989
Decision Date January 22, 1990
Days to Decision 75 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
55d faster than avg
Panel avg: 130d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K896426.
RESECTOSCOPE LOOPS
K903323 · Olympus Corp. · Oct 1990
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K901443 · Wilson-Cook Medical, Inc. · Jun 1990
DOBBHOFF(R) PAPILLOTOME
K896612 · Biosearch Medical Products, Inc. · Feb 1990
MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · Cook Urological, Inc. · Aug 1988
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · Cooper Lasersonics, Inc. · Dec 1986