Cleared Special

K052338 - SOLAR GI (FDA 510(k) Clearance)

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

K052338 · Medical Measurement Systems B.V. · Gastroenterology & Urology device
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Dec 2005
Decision
111d
Days
Class 2
Risk

K052338 is an FDA 510(k) clearance for the SOLAR GI. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Medical Measurement Systems B.V. (Enschede Overijssel, NL). The FDA issued a Cleared decision on December 15, 2005 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 Medical Measurement Systems B.V. devices

Submission Details

510(k) Number K052338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date December 15, 2005
Days to Decision 111 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 - FFX System, Gastrointestinal Motility (electrical)

All 68
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