Cleared Special

K123170 - VARI-PASS VARIABLE LENGTH ACCESS SHEATH (FDA 510(k) Clearance)

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

K123170 · Olympus Surgical Technologies America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
118d
Days
Class 2
Risk

K123170 is an FDA 510(k) clearance for the VARI-PASS VARIABLE LENGTH ACCESS SHEATH. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on February 4, 2013 after a review of 118 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 Olympus Surgical Technologies America devices

Submission Details

510(k) Number K123170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date February 04, 2013
Days to Decision 118 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
12d faster than avg
Panel avg: 130d · This submission: 118d
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.