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FDA 510(k)

PointerShell Universal, PointerShell LS

K-Number: K160479 · 2016-03-23

ApplicantFiagon GmbH
Decision Date2016-03-23
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PointerShell Universal, PointerShell LS is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2016-03-23 under 510(k) 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. The listed applicant is Fiagon GmbH. The 510(k) number is K160479.

When did PointerShell Universal, PointerShell LS receive FDA 510(k) clearance?

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

Who is the listed applicant for PointerShell Universal, PointerShell LS?

The FDA 510(k) record lists Fiagon GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

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