FDA 510(k)

Three Way Stop Cock

Numéro K : K223499 · 2023-07-21

Date de décision2023-07-21

Code produitFMG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Three Way Stop Cock is the device name listed in this FDA 510(k) record. The listed applicant is M/S Romsons International. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K223499. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Three Way Stop Cock?

Three Way Stop Cock is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is M/S Romsons International. The 510(k) number is K223499.

When did Three Way Stop Cock receive FDA 510(k) clearance?

Three Way Stop Cock received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223499.

Who is the listed applicant for Three Way Stop Cock?

The FDA 510(k) record lists M/S Romsons International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Three Way Stop Cock?

The FDA product code for Three Way Stop Cock is FMG.

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 : FMG)

K242255Qitexio® 4-Way Stopcock (QIT014)Medex K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal K210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC K190489Elcam Stopcocks and ManifoldsElcam Medical Acal

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.