FDA 510(k)

PointerShell Universal, PointerShell LS

K-Number: K160479 · 2016-03-23

Decision Date2016-03-23

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PointerShell Universal, PointerShell LS is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2016-03-23 under approval number K160479. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PointerShell Universal, PointerShell LS?

PointerShell Universal, PointerShell LS is a medical device that received FDA 510(k) clearance on 2016-03-23. It is manufactured by Fiagon GmbH. The 510(k) number is K160479.

When was PointerShell Universal, PointerShell LS approved by the FDA?

PointerShell Universal, PointerShell LS received FDA 510(k) clearance on 2016-03-23, under approval number K160479.

What company makes PointerShell Universal, PointerShell LS?

PointerShell Universal, PointerShell LS is manufactured by Fiagon GmbH.

What is the FDA product code for PointerShell Universal, PointerShell LS?

The FDA product code for PointerShell Universal, PointerShell LS is PGW.

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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.