FDA 510(k)

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

N.º K: K202783 · 2022-01-14

SolicitanteSmith & Nephew Medical Limited

Fecha de decisión2022-01-14

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K202783. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K202783.

When did Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing receive FDA 510(k) clearance?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing received FDA 510(k) clearance on 2022-01-14, under 510(k) number K202783.

Who is the listed applicant for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

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

What is the FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

The FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is OMP.

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Otros registros que enlistan a Smith & Nephew Medical Limited como solicitante

K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing K220964VERSAJET Hydrosurgery System (III)K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large K223041Renasys Edge (66803126)K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System

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Fuente oficial

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