FDA 510(k)

EMPOWR blade stem

K-Number: K223779 · 2023-02-13

Decision Date2023-02-13

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMPOWR blade stem is a medical device manufactured by Encore Medical, LLC. It received FDA 510(k) clearance on 2023-02-13 under approval number K223779. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR blade stem?

EMPOWR blade stem is a medical device that received FDA 510(k) clearance on 2023-02-13. It is manufactured by Encore Medical, LLC. The 510(k) number is K223779.

When was EMPOWR blade stem approved by the FDA?

EMPOWR blade stem received FDA 510(k) clearance on 2023-02-13, under approval number K223779.

What company makes EMPOWR blade stem?

EMPOWR blade stem is manufactured by Encore Medical, LLC.

What is the FDA product code for EMPOWR blade stem?

The FDA product code for EMPOWR blade stem is LPH.

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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.