FDA 510(k)

Smith & Nephew DYONICS 25 Fluid Management System

K-Number: K192155 · 2019-09-04

Decision Date2019-09-04

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew DYONICS 25 Fluid Management System 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 2019-09-04 under 510(k) number K192155. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew DYONICS 25 Fluid Management System?

Smith & Nephew DYONICS 25 Fluid Management System is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K192155.

When did Smith & Nephew DYONICS 25 Fluid Management System receive FDA 510(k) clearance?

Smith & Nephew DYONICS 25 Fluid Management System received FDA 510(k) clearance on 2019-09-04, under 510(k) number K192155.

Who is the listed applicant for Smith & Nephew DYONICS 25 Fluid Management System?

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 DYONICS 25 Fluid Management System?

The FDA product code for Smith & Nephew DYONICS 25 Fluid Management System is HRX.

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Other records listing Smith & Nephew, Inc. as applicant

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Official Source

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