FDA 510(k)

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

Numéro K : K143153 · 2016-01-15

Date de décision2016-01-15

Code produitFDT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V 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 2016-01-15 under 510(k) number K143153. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K143153.

When did EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V receive FDA 510(k) clearance?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V received FDA 510(k) clearance on 2016-01-15, under 510(k) number K143153.

Who is the listed applicant for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

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 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

The FDA product code for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is FDT.

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 Olympus Medical Systems Corp. en tant que demandeur

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Poignée actionnée à l'avant Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Poignée actionnée à l'avant Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Poignée actionnée à l'avant 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)

Voir tous les 80 dispositifs →

Dispositifs connexes (Code : FDT)

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

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.