Decision Date2022-11-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
H1 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 2022-11-10 under 510(k) number K222504. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the H1?
H1 is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K222504.
When did H1 receive FDA 510(k) clearance?
H1 received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222504.
Who is the listed applicant for H1?
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 H1?
The FDA product code for H1 is GCJ.
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.