ClearCap Distal Attachment
K-Number: K202616 · 2021-02-19
ApplicantFinemedix Co., Ltd.
Decision Date2021-02-19
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ClearCap Distal Attachment is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under approval number K202616. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearCap Distal Attachment?
ClearCap Distal Attachment is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K202616.
When was ClearCap Distal Attachment approved by the FDA?
ClearCap Distal Attachment received FDA 510(k) clearance on 2021-02-19, under approval number K202616.
What company makes ClearCap Distal Attachment?
ClearCap Distal Attachment is manufactured by Finemedix Co., Ltd..
What is the FDA product code for ClearCap Distal Attachment?
The FDA product code for ClearCap Distal Attachment is OCX.
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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.