FDA 510(k)

AVELLA Système de thérapie par décompression negative des plaies

Numéro K : K180205 · 2018-10-19

Date de décision2018-10-19

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AVELLE Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K180205. 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 AVELLE Negative Pressure Wound Therapy System?

AVELLE Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Convatec Limited. The 510(k) number is K180205.

When did AVELLE Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

AVELLE Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-10-19, under 510(k) number K180205.

Who is the listed applicant for AVELLE Negative Pressure Wound Therapy System?

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

What is the FDA product code for AVELLE Negative Pressure Wound Therapy System?

The FDA product code for AVELLE Negative Pressure Wound Therapy System is OMP.

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Autres dossiers indiquant Convatec Limited en tant que demandeur

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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

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