FDA 510(k)

SMITH & NEPHEW RF CANNULATE

K-Number: K090955 · 2009-07-16

Decision Date2009-07-16

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW RF CANNULATE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2009-07-16 under 510(k) number K090955. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW RF CANNULATE?

SMITH & NEPHEW RF CANNULATE is a medical device that received FDA 510(k) clearance on 2009-07-16. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K090955.

When did SMITH & NEPHEW RF CANNULATE receive FDA 510(k) clearance?

SMITH & NEPHEW RF CANNULATE received FDA 510(k) clearance on 2009-07-16, under 510(k) number K090955.

Who is the listed applicant for SMITH & NEPHEW RF CANNULATE?

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

What is the FDA product code for SMITH & NEPHEW RF CANNULATE?

The FDA product code for SMITH & NEPHEW RF CANNULATE is GXI.

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Related Devices (Code: GXI)

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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.