Cleared Traditional

K802187 - STERILE DISPOSABLE CYTOLOGY BRUSH (FDA 510(k) Clearance)

K802187 · Olympus Corp. · Gastroenterology & Urology device
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Sep 1980
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K802187 is an FDA 510(k) clearance for the STERILE DISPOSABLE CYTOLOGY BRUSH.

Submitted by Olympus Corp. (Mchenry, US). The FDA issued a Cleared decision on September 10, 1980.

This device falls under the Gastroenterology & Urology FDA review panel. 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 K802187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received September 10, 1980
Decision Date September 10, 1980
Days to Decision -
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -