Cleared Traditional

K252646 - Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (FDA 510(k) Clearance)

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

K252646 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
64d
Days
Class 2
Risk

K252646 is an FDA 510(k) clearance for the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H). 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 24, 2025 after a review of 64 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 Corp. devices

Submission Details

510(k) Number K252646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2025
Decision Date October 24, 2025
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
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
Jillian Connery

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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K252646.
ClearTip FNA and FNB Types
K250994 · Finemedix Co., Ltd. · Aug 2025
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · Cook Ireland, Ltd. · Jul 2024
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023
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