Cleared Traditional

K950087 - LOT 440

K950087 is an FDA 510(k) clearance for LOT 440, manufactured by Medical Instruments Corporation Mic AG. The device is a Class 1 Gastroenterology & Urology device with product code FFT cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K950087 · Medical Instruments Corporation Mic AG · Gastroenterology & Urology device
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Feb 1996
Decision
392d
Days
Class 1
Risk

K950087 is an FDA 510(k) clearance for the LOT 440. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Medical Instruments Corporation Mic AG (Solothurn, CH). The FDA issued a Cleared decision on February 6, 1996 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1400 - 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. Elevated predicate reliance profile. 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 Instruments Corporation Mic AG devices

FDA 510(k) Submission Details - K950087

510(k) Number K950087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date February 06, 1996
Days to Decision 392 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 130d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

FFT Device Classification - Class 1, General Controls

Product Code FFT Electrode, Ph, Stomach
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FFT Electrode, Ph, Stomach

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