Cleared Traditional

K071094 - MODIFICATION TO SOLAR GI

K071094 is an FDA 510(k) clearance for MODIFICATION TO SOLAR GI, manufactured by Medical Measurement Systems B.V.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K071094 · Medical Measurement Systems B.V. · Gastroenterology & Urology device
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Aug 2007
Decision
117d
Days
Class 2
Risk

K071094 is an FDA 510(k) clearance for the MODIFICATION TO 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 August 13, 2007 after a review of 117 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Measurement Systems B.V. devices

FDA 510(k) Submission Details - K071094

510(k) Number K071094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date August 13, 2007
Days to Decision 117 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 131d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFX Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K071094.
ENDOFLIP
K092850 · Crospon, Ltd. · Dec 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
K091070 · Sierra Scientific Instruments, Inc. · May 2009
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
K082056 · Life-Tech, Inc. · Nov 2008
UNITIP HIGH RESOLUTION CATHETER
K062222 · Unisensor AG · Mar 2007
OHMEGA
K060166 · Medical Measurement Systems B.V. · Apr 2006
SOLAR GI
K052338 · Medical Measurement Systems B.V. · Dec 2005