ClearCap Distal Attachment— 510(k) K242134

Substantially Equivalent

Finemedix Co., Ltd.

FDA 510(k) clearance K242134 for ClearCap Distal Attachment, Substantially Equivalent on 2024-08-20. Applicant: Finemedix Co., Ltd.. Device class: 2.

Clearance details

Applicant: Finemedix Co., Ltd.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-22
Decision date: 2024-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Finemedix Co., Ltd.

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K231267 — ClearTip2023-06-30
K202616 — ClearCap Distal Attachment2021-02-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.