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FDA 510(k)

ClearCap Distal Attachment

K-Number: K242134 · 2024-08-20

Decision Date2024-08-20
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 2024-08-20 under approval number K242134. 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 2024-08-20. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K242134.

When was ClearCap Distal Attachment approved by the FDA?

ClearCap Distal Attachment received FDA 510(k) clearance on 2024-08-20, under approval number K242134.

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.

Other Devices by Finemedix Co., Ltd.

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Related Devices (Code: OCX)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.