Cleared Special

UPDATED SLIP UROLOGY INTRODUCER SHEATH (K042531) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042531 · Percutaneous Systems, Incorporated · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
137d
Days
Class 2
Risk

K042531 is an FDA 510(k) clearance for the UPDATED SLIP UROLOGY INTRODUCER SHEATH. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Percutaneous Systems, Incorporated devices

Submission Details

510(k) Number K042531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date February 01, 2005
Days to Decision 137 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 130d · This submission: 137d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNY Accessories, Catheter, G-u
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.