Cleared Traditional

K760184 - ELEMENT, WORKING (FDA 510(k) Clearance)

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

K760184 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology device
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Dec 1976
Decision
149d
Days
Class 2
Risk

K760184 is an FDA 510(k) clearance for the ELEMENT, WORKING. Classified as Resectoscope, Working Element (product code FDC), Class II - Special Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date December 02, 1976
Days to Decision 149 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
19d slower than avg
Panel avg: 130d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDC Resectoscope, Working Element
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.