Optimos Cystotome
K-Number: K223256 · 2023-04-05
ApplicantTaewoong Medical Co., Ltd.
Decision Date2023-04-05
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Optimos Cystotome is a medical device manufactured by Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under approval number K223256. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optimos Cystotome?
Optimos Cystotome is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Taewoong Medical Co., Ltd.. The 510(k) number is K223256.
When was Optimos Cystotome approved by the FDA?
Optimos Cystotome received FDA 510(k) clearance on 2023-04-05, under approval number K223256.
What company makes Optimos Cystotome?
Optimos Cystotome is manufactured by Taewoong Medical Co., Ltd..
What is the FDA product code for Optimos Cystotome?
The FDA product code for Optimos Cystotome is KNS.
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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.