FDA 510(k)

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

Numéro K : K243576 · 2025-02-18

Date de décision2025-02-18

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2025-02-18 under 510(k) number K243576. 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 Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port?

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port is a medical device that received FDA 510(k) clearance on 2025-02-18. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K243576.

When did RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port receive FDA 510(k) clearance?

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243576.

Who is the listed applicant for RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port?

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

What is the FDA product code for RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port?

The FDA product code for RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port is OMP.

Essais cliniques associés

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Autres dossiers indiquant Smith & Nephew Medical, Ltd. en tant que demandeur

K261338RENASYS DYNAFLOW Kit (66807741)K260646RENASYS EDGE (66803126)K251826RENASYS WOUND+ Dressing Kit with AIRLOCK Technology K231939Renasys Edge K190756IODOFLEX K190730IODOSORB

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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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