FDA 510(k)

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

Numéro K : K160416 · 2016-05-20

Date de décision2016-05-20

Code produitOWN

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160416. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Mauna Kea Technologies. The 510(k) number is K160416.

When did CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes receive FDA 510(k) clearance?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160416.

Who is the listed applicant for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

The FDA 510(k) record lists Mauna Kea Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

The FDA product code for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is OWN.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Autres dossiers indiquant Mauna Kea Technologies en tant que demandeur

K220477Cellvizio 100 series system with confocal Miniprobes K212322Cellvizio I.V.E. system with Confocal Miniprobes K193416Cellvizio I.V.E. with Confocal Miniprobes K191144Cellvizio 100 Series System with Confocal Miniprobes K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes K180270Cellvizio 100 Series Systems with Confocal Miniprobes

Voir tous les 9 dispositifs →

Dispositifs connexes (Code : OWN)

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker Endoscopy

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.