Cleared Traditional

K943304 - 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY

K943304 is the FDA 510(k) clearance for 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 530-day FDA review.

K943304 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 54
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K943304.
SMARTGUIDE
K963894 · Ferguson Medical · Mar 1997
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K961897 · Wilson-Cook Medical, Inc. · Jan 1997
DAUM BIOPSYNEEDLE
K961185 · Ferguson Medical · Apr 1996
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994