FDA 510(k)

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Numéro K : K213853 · 2023-02-10

DemandeurSmith and Nephew Medical Limited

Date de décision2023-02-10

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Medical Limited. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K213853. 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 RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Smith and Nephew Medical Limited. The 510(k) number is K213853.

When did RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large receive FDA 510(k) clearance?

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large received FDA 510(k) clearance on 2023-02-10, under 510(k) number K213853.

Who is the listed applicant for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

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

What is the FDA product code for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large?

The FDA product code for RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large is OMP.

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Source officielle

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