Cleared Traditional

K063700 - SPYGLASS IRRIGATION SYSTEM

K063700 is an FDA 510(k) clearance for SPYGLASS IRRIGATION SYSTEM, manufactured by Medical Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K063700 · Medical Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
57d
Days
Class 2
Risk

K063700 is an FDA 510(k) clearance for the 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 February 8, 2007 after a review of 57 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. 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 Medical Scientific, Inc. devices

FDA 510(k) Submission Details - K063700

510(k) Number K063700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date February 08, 2007
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LJH System, Irrigation, Urological

All 17
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K063700.
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