Cleared Traditional

K931763 - HF-RESECTION ELECTRODE

K931763 is an FDA 510(k) clearance for HF-RESECTION ELECTRODE, manufactured by Olympus Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 508-day FDA review.

K931763 · Olympus Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
508d
Days
Class 2
Risk

K931763 is an FDA 510(k) clearance for the HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on August 29, 1994 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Olympus Corp. devices

FDA 510(k) Submission Details - K931763

510(k) Number K931763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date August 29, 1994
Days to Decision 508 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
378d slower than avg
Panel avg: 130d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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.