H1
K-Number: K222504 · 2022-11-10
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2022-11-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
H1 is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval 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. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K222504.
When was H1 approved by the FDA?
H1 received FDA 510(k) clearance on 2022-11-10, under approval number K222504.
What company makes H1?
H1 is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for H1?
The FDA product code for H1 is GCJ.
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K162880TIPCAM 1S 3D System
K162410TIPCAM 1S 3D System
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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.