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FDA 510(k)

RENASYS-G Gauze Dressing Kits with Soft Port

K-Number: K162129 · 2016-08-31

ApplicantSmith & Nephew, Inc.
Decision Date2016-08-31
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS-G Gauze Dressing Kits with Soft Port is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval number K162129. 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-G Gauze Dressing Kits with Soft Port?

RENASYS-G Gauze Dressing Kits with Soft Port is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K162129.

When was RENASYS-G Gauze Dressing Kits with Soft Port approved by the FDA?

RENASYS-G Gauze Dressing Kits with Soft Port received FDA 510(k) clearance on 2016-08-31, under approval number K162129.

What company makes RENASYS-G Gauze Dressing Kits with Soft Port?

RENASYS-G Gauze Dressing Kits with Soft Port is manufactured by Smith & Nephew, Inc..

What is the FDA product code for RENASYS-G Gauze Dressing Kits with Soft Port?

The FDA product code for RENASYS-G Gauze Dressing Kits with Soft Port is OMP.

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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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