FDA 510(k)

Foryou NPWT Dressing Kit

Numéro K : K190119 · 2019-11-01

Date de décision2019-11-01

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Foryou NPWT Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is 4l Health Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190119. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Foryou NPWT Dressing Kit?

Foryou NPWT Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is 4l Health Co., Ltd.. The 510(k) number is K190119.

When did Foryou NPWT Dressing Kit receive FDA 510(k) clearance?

Foryou NPWT Dressing Kit received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190119.

Who is the listed applicant for Foryou NPWT Dressing Kit?

The FDA 510(k) record lists 4l Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foryou NPWT Dressing Kit?

The FDA product code for Foryou NPWT Dressing Kit is OMP.

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 : OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

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.