ClearCap Distal Attachment— 510(k) K202616

Substantially Equivalent

Finemedix Co., Ltd.

FDA 510(k) clearance K202616 for ClearCap Distal Attachment, Substantially Equivalent on 2021-02-19. 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: 2020-09-09
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Finemedix Co., Ltd.

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K242134 — ClearCap Distal Attachment2024-08-20
K231267 — ClearTip2023-06-30

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