Cleared Traditional

K050503 - SINGLE USE ASPIRATION NEEDLE NA-201SX-4022

K050503 is the FDA 510(k) clearance for SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K050503 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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May 2005
Decision
73d
Days
Class 2
Risk

K050503 is an FDA 510(k) clearance for the SINGLE USE ASPIRATION NEEDLE NA-201SX-4022. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on May 12, 2005 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K050503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date May 12, 2005
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
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 49
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K050503.
TISSUE SAMPLING NEEDLE
K103694 · United States Endoscopy Group, Inc. · Jul 2011
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · Boston Scientific Corporation · Mar 2010
TROKABONE, TROKABONE STERNAL
K070179 · PAJUNK GmbH Medizintechnologie · Mar 2007
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005
EASY CORE BIOPSY SYSTEM
K040893 · Boston Scientific Corp · May 2004
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003