FDA 510(k)

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

K-Nummer: K252646 · 2025-10-24

AntragstellerOlympus Medical Systems Corp.

Entscheidungsdatum2025-10-24

ProduktcodeFCG

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Olympus Medical Systems Corp. als Antragsteller

K2620794K Camera Head OLYMPUS CH-S700-08-LB 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)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)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

Alle 80 Geräte anzeigen →

Verwandte Geräte (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

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.