Decision Date2023-04-27
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
UNIDRIVE SIII System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz-Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) 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. The listed applicant is Karl Storz-Endoscopy-America, Inc.. The 510(k) number is K223520.
When did UNIDRIVE SIII System receive FDA 510(k) clearance?
UNIDRIVE SIII System received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223520.
Who is the listed applicant for UNIDRIVE SIII System?
The FDA 510(k) record lists Karl Storz-Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UNIDRIVE SIII System?
The FDA product code for UNIDRIVE SIII System is HIH.
Other records listing Karl Storz-Endoscopy-America, Inc. as applicant
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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.