Cleared Traditional

K895420 - SUCTION BIOPSY INSTRUMENT (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895420 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Feb 1990
Decision
161d
Days
Class 2
Risk

K895420 is an FDA 510(k) clearance for the SUCTION BIOPSY INSTRUMENT. Classified as Instrument, Biopsy, Suction (product code FCK), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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.

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Submission Details

510(k) Number K895420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date February 09, 1990
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCK Instrument, Biopsy, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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.