RENASYS GO
K-Number: K152163 · 2016-09-29
ApplicantSmith & Nephew, Inc.
Decision Date2016-09-29
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
RENASYS GO is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-09-29 under approval number K152163. 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 GO?
RENASYS GO is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K152163.
When was RENASYS GO approved by the FDA?
RENASYS GO received FDA 510(k) clearance on 2016-09-29, under approval number K152163.
What company makes RENASYS GO?
RENASYS GO is manufactured by Smith & Nephew, Inc..
What is the FDA product code for RENASYS GO?
The FDA product code for RENASYS GO 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.