Cleared Special

K071832 - MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (FDA 510(k) Clearance)

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

K071832 · Medical Scientific, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
77d
Days
Class 2
Risk

K071832 is an FDA 510(k) clearance for the MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Medical Scientific, Inc. (Taunton, US). The FDA issued a Cleared decision on September 18, 2007 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 876.5130 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Scientific, Inc. devices

Submission Details

510(k) Number K071832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date September 18, 2007
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJH System, Irrigation, Urological
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.