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FDA 510(k)

KARL STORZ OR1™ SCB CONTROL (WU300)

K-Number: K232406 · 2023-10-03

ApplicantKarl Storz SE & CO. KG
Decision Date2023-10-03
Product CodeODA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ OR1™ SCB CONTROL (WU300) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232406. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ OR1™ SCB CONTROL (WU300)?

KARL STORZ OR1™ SCB CONTROL (WU300) is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232406.

When did KARL STORZ OR1™ SCB CONTROL (WU300) receive FDA 510(k) clearance?

KARL STORZ OR1™ SCB CONTROL (WU300) received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232406.

Who is the listed applicant for KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300) is ODA.

Other records listing Karl Storz SE & CO. KG as applicant

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Related Devices (Code: ODA)

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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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