Cleared Traditional

K896376 - PORGES NASOBILIARY DRAIN

K896376 is an FDA 510(k) clearance for PORGES NASOBILIARY DRAIN, manufactured by Porges Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K896376 · Porges Corp. · Gastroenterology & Urology device
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Jan 1990
Decision
77d
Days
Class 2
Risk

K896376 is an FDA 510(k) clearance for the PORGES NASOBILIARY DRAIN. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Porges Corp. (Gary, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 77 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 Porges Corp. devices

FDA 510(k) Submission Details - K896376

510(k) Number K896376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date January 22, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 412
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K896376.
PORGES ERCP CATHETERS
K896503 · Porges Corp. · Jan 1990
PORGES 2-WAY BALLOON EXTRACTION CATHETER
K896504 · Porges Corp. · Jan 1990
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
K896506 · Porges Corp. · Jan 1990
PORGES BILIARY STENTS
K896423 · Porges Corp. · Jan 1990
WILTEK E.R.C.P. CATHETER
K894867 · Wiltek Medical, Inc. · Dec 1989
WILTEK BILIARY STENT SET
K894871 · Wiltek Medical, Inc. · Dec 1989