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FDA 510(k)

RENASYS Touch; RENASYS Y-Connector

K-Number: K181822 · 2019-03-21

ApplicantSmith & Nephew Medical Limited
Decision Date2019-03-21
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS Touch; RENASYS Y-Connector is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-03-21 under approval number K181822. 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 Touch; RENASYS Y-Connector?

RENASYS Touch; RENASYS Y-Connector is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K181822.

When was RENASYS Touch; RENASYS Y-Connector approved by the FDA?

RENASYS Touch; RENASYS Y-Connector received FDA 510(k) clearance on 2019-03-21, under approval number K181822.

What company makes RENASYS Touch; RENASYS Y-Connector?

RENASYS Touch; RENASYS Y-Connector is manufactured by Smith & Nephew Medical Limited.

What is the FDA product code for RENASYS Touch; RENASYS Y-Connector?

The FDA product code for RENASYS Touch; RENASYS Y-Connector 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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