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FDA 510(k)

Endomat Select, IBS Shaver Software, License

K-Number: K201355 · 2020-07-22

ApplicantKarl Storz SE & CO. KG
Decision Date2020-07-22
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endomat Select, IBS Shaver Software, License is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-07-22 under approval number K201355. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endomat Select, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K201355.

When was Endomat Select, IBS Shaver Software, License approved by the FDA?

Endomat Select, IBS Shaver Software, License received FDA 510(k) clearance on 2020-07-22, under approval number K201355.

What company makes Endomat Select, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for Endomat Select, IBS Shaver Software, License?

The FDA product code for Endomat Select, IBS Shaver Software, License is HIG.

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Related Devices (Code: HIG)

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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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