Cleared Traditional

K920574 - CAMSYS 6300 (FDA 510(k) Clearance)

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

K920574 · F.M. Wiest USA, Inc. · Gastroenterology & Urology device
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Feb 1993
Decision
376d
Days
Class 2
Risk

K920574 is an FDA 510(k) clearance for the CAMSYS 6300. Classified as Cystometer, Electrical Recording (product code EXQ), Class II - Special Controls.

Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on February 17, 1993 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 F.M. Wiest USA, Inc. devices

Submission Details

510(k) Number K920574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date February 17, 1993
Days to Decision 376 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 130d · This submission: 376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXQ Cystometer, Electrical Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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.