FDA 510(k)

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

K-Nummer: K243550 · 2025-06-06

Entscheidungsdatum2025-06-06

ProduktcodeFGB

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K243550. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K243550.

When did KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) receive FDA 510(k) clearance?

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K243550.

Who is the listed applicant for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

The FDA product code for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is FGB.

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 Karl Storz SE & CO. KG als Antragsteller

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

Alle 33 Geräte anzeigen →

Verwandte Geräte (Code: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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.