FDA 510(k)

Modulith SLX-F2

K-Number: K201001 · 2021-03-30

Decision Date2021-03-30

Product CodeLNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Modulith SLX-F2 is a medical device manufactured by Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-03-30 under approval number K201001. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modulith SLX-F2?

Modulith SLX-F2 is a medical device that received FDA 510(k) clearance on 2021-03-30. It is manufactured by Karl Storz Endoscopy America. The 510(k) number is K201001.

When was Modulith SLX-F2 approved by the FDA?

Modulith SLX-F2 received FDA 510(k) clearance on 2021-03-30, under approval number K201001.

What company makes Modulith SLX-F2?

Modulith SLX-F2 is manufactured by Karl Storz Endoscopy America.

What is the FDA product code for Modulith SLX-F2?

The FDA product code for Modulith SLX-F2 is LNS.

Other Devices by Karl Storz Endoscopy America

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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.