FDA 510(k)

Creo Electrosurgical System with NP1 Instrument

K-Nummer: K221672 · 2023-02-14

Entscheidungsdatum2023-02-14

ProduktcodeNEY

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Creo Electrosurgical System with NP1 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-02-14 under 510(k) number K221672. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Creo Electrosurgical System with NP1 Instrument?

Creo Electrosurgical System with NP1 Instrument is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K221672.

When did Creo Electrosurgical System with NP1 Instrument receive FDA 510(k) clearance?

Creo Electrosurgical System with NP1 Instrument received FDA 510(k) clearance on 2023-02-14, under 510(k) number K221672.

Who is the listed applicant for Creo Electrosurgical System with NP1 Instrument?

The FDA 510(k) record lists Creo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Creo Electrosurgical System with NP1 Instrument?

The FDA product code for Creo Electrosurgical System with NP1 Instrument is NEY.

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 Creo Medical, Ltd. als Antragsteller

K242774SpydrBlade Flex Instrument (PRD-RG1-001)K242983CROMA Electrosurgical Generator (PRD-EMR-050)K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)K230328Speedboat Flush SB1 Instrument K223138AB1 Elektrosurgisches Instrument, Creo Elektrosurgisches System K200298ABI Instrument, Creo Elektrosurgisches System

Alle 10 Geräte anzeigen →

Verwandte Geräte (Code: NEY)

K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.

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.