HOPKINS Telescopes
K-Number: K221004 · 2022-12-20
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2022-12-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HOPKINS Telescopes is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K221004. 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 HOPKINS Telescopes?
HOPKINS Telescopes is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K221004.
When was HOPKINS Telescopes approved by the FDA?
HOPKINS Telescopes received FDA 510(k) clearance on 2022-12-20, under approval number K221004.
What company makes HOPKINS Telescopes?
HOPKINS Telescopes is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for HOPKINS Telescopes?
The FDA product code for HOPKINS Telescopes is GCJ.
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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.