FDA 510(k)

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

K-Number: K252646 · 2025-10-24

Decision Date2025-10-24

Product CodeFCG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-10-24 under approval number K252646. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K252646.

When was Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) approved by the FDA?

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) received FDA 510(k) clearance on 2025-10-24, under approval number K252646.

What company makes Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

The FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is FCG.

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Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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Related Devices (Code: FCG)

K160423Perineologic Access NeedleCorbin Clinical Resources, LLC K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp. K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd. K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical, Inc. K160890Howell Biliary Introducer NeedleWilson-Cook Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.