Cleared Traditional

K911581 - PALMAZ(TM) BALLOON-EXPANDABLE STENT

K911581 is an FDA 510(k) clearance for PALMAZ(TM) BALLOON-EXPANDABLE STENT, manufactured by Johnson & Johnson Interventional Systems. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K911581 · Johnson & Johnson Interventional Systems · Gastroenterology & Urology device
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Jun 1991
Decision
56d
Days
Class 2
Risk

K911581 is an FDA 510(k) clearance for the PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Johnson & Johnson Interventional Systems (Warren, US). The FDA issued a Cleared decision on June 4, 1991 after a review of 56 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 Johnson & Johnson Interventional Systems devices

FDA 510(k) Submission Details - K911581

510(k) Number K911581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date June 04, 1991
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K911581.
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · Baxter Healthcare Corp · Sep 1991
INTHERM RADIALLY EXPANDING DILATER
K912971 · Interventional Therapeutics Corp. · Sep 1991
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · Boston Scientific Corp · Aug 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
BALLOON CATHETERS
K904669 · Olympus Corp. · Mar 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · Baxter Healthcare Corp · Feb 1991