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FDA 510(k)

UNIDRIVE SIII System

K-Number: K223520 · 2023-04-27

ApplicantKarl Storz-Endoscopy-America, Inc.
Decision Date2023-04-27
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UNIDRIVE SIII System is a medical device manufactured by Karl Storz-Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2023-04-27 under approval number K223520. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIDRIVE SIII System?

UNIDRIVE SIII System is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by Karl Storz-Endoscopy-America, Inc.. The 510(k) number is K223520.

When was UNIDRIVE SIII System approved by the FDA?

UNIDRIVE SIII System received FDA 510(k) clearance on 2023-04-27, under approval number K223520.

What company makes UNIDRIVE SIII System?

UNIDRIVE SIII System is manufactured by Karl Storz-Endoscopy-America, Inc..

What is the FDA product code for UNIDRIVE SIII System?

The FDA product code for UNIDRIVE SIII System is HIH.

Other Devices by Karl Storz-Endoscopy-America, Inc.

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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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