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 the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K252646.

When did Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) receive FDA 510(k) clearance?

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

Who is the listed applicant for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Olympus Medical Systems Corp. as applicant

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LB K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: FCG)

K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.K212423EndoDrill® Model XBibbinstruments AB

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.