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FDA 510(k)

ClearCap Distal Attachment

K-Number: K242134 · 2024-08-20

ApplicantFinemedix Co., Ltd.
Decision Date2024-08-20
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearCap Distal Attachment is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) 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. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K242134.

When did ClearCap Distal Attachment receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearCap Distal Attachment?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearCap Distal Attachment?

The FDA product code for ClearCap Distal Attachment is OCX.

Other records listing Finemedix Co., Ltd. as applicant

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Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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