Cleared Traditional

K180668 - Single Use Aspiration Needle NA-U401SX-...

K180668 is the FDA 510(k) clearance for Single Use Aspiration Needle NA-U401SX-... by Olympus Medical Systems Corp.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K180668 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Nov 2018
Decision
246d
Days
Class 2
Risk

K180668 is an FDA 510(k) clearance for the Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 15, 2018 after a review of 246 days - an extended review 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: 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K180668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date November 15, 2018
Days to Decision 246 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
116d slower than avg
Panel avg: 130d · This submission: 246d
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 Consultant

Olympus Corporation of the Americas
Sheri L. Musgnung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FCG Biopsy Needle

All 49
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K180668.
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
K210476 · Cook Ireland, Ltd. · May 2021
Biopsy Needle
K191472 · Ushare Medical, Inc. · Jan 2020
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · Apriomed AB · Dec 2018
Clear-Tip EUS-FNA
K180363 · Finemedix Co., Ltd. · Nov 2018
Single Use Aspiration Needle NA-U201H
K181994 · Olympus Medical Systems Corp. · Oct 2018
Single Use Aspiration Needle NA-U200H
K180449 · Olympus Medical Systems Corp. · Jun 2018