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FDA 510(k)

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

K-Number: K202783 · 2022-01-14

ApplicantSmith & Nephew Medical Limited
Decision Date2022-01-14
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Smith & Nephew Medical Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260646RENASYS EDGE (66803126)K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyK243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft PortK242146BIOBRANE Temporary Wound Dressing; BIOBRANE GloveK231939Renasys EdgeK223526ALLEVYN 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

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Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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