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FDA 510(k)

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

K-Number: K233333 · 2023-11-21

Decision Date2023-11-21
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2023-11-21 under approval number K233333. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K233333.

When was KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit approved by the FDA?

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit received FDA 510(k) clearance on 2023-11-21, under approval number K233333.

What company makes KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit?

The FDA product code for KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit is OWN.

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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.