FDA 510(k)

AED Sinuscope

Numéro K : K170285 · 2017-08-01

DemandeurNational Advanced Endoscopy Devices, Inc.

Date de décision2017-08-01

Code produitEOB

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

AED Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170285. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AED Sinuscope?

AED Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K170285.

When did AED Sinuscope receive FDA 510(k) clearance?

AED Sinuscope received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170285.

Who is the listed applicant for AED Sinuscope?

The FDA 510(k) record lists National Advanced Endoscopy Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AED Sinuscope?

The FDA product code for AED Sinuscope is EOB.

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

Dispositifs connexes (Code : EOB)

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KG K261544Hydro Irrigation SystemStryker Instruments K254133ENTity USB Videoscope SystemOptim, LLC K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook Surgical Versa One System (8900139)Resnent, LLC

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.