Cleared Traditional

K181994 - Single Use Aspiration Needle NA-U201H

K181994 is the FDA 510(k) clearance for Single Use Aspiration Needle NA-U201H 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 97-day FDA review.

K181994 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Oct 2018
Decision
97d
Days
Class 2
Risk

K181994 is an FDA 510(k) clearance for the Single Use Aspiration Needle NA-U201H. 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 October 31, 2018 after a review of 97 days - within the typical 510(k) review window.

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 K181994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2018
Decision Date October 31, 2018
Days to Decision 97 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
33d faster than avg
Panel avg: 130d · This submission: 97d
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 Surgical Technologies America
Mary Anne Patella

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 K181994.
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · Apriomed AB · Dec 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K180668 · Olympus Medical Systems Corp. · Nov 2018
Clear-Tip EUS-FNA
K180363 · Finemedix Co., Ltd. · Nov 2018
Single Use Aspiration Needle NA-U200H
K180449 · Olympus Medical Systems Corp. · Jun 2018
Beacon EUS Access System
K180037 · Covidien, LLC · Apr 2018
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K171596 · Wilson-Cook Medical, Inc. · Aug 2017