Cleared Traditional

K943304 - 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY (FDA 510(k) Clearance)

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

K943304 · Olympus America, Inc. · Gastroenterology & Urology device
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Dec 1995
Decision
530d
Days
Class 2
Risk

K943304 is an FDA 510(k) clearance for the 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on December 20, 1995 after a review of 530 days - an unusually long review period, suggesting complex equivalence evaluation.

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

Submission Details

510(k) Number K943304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date December 20, 1995
Days to Decision 530 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
400d slower than avg
Panel avg: 130d · This submission: 530d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
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.

Regulatory Peers - FCG Biopsy Needle

All 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K943304.
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Precision GI
K231422 · Limaca Medical, Ltd. · Aug 2023
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023