AFS Medical Sterile Single-Use Access Port System— 510(k) K202688

Name: FDA 510(k) clearance K202688
Creator: U.S. Food and Drug Administration
Published: 2021-10-14

Substantially Equivalent

Afs Medical Co. , Ltd.

FDA 510(k) clearance K202688 for AFS Medical Sterile Single-Use Access Port System, Substantially Equivalent on 2021-10-14. Applicant: Afs Medical Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Afs Medical Co. , Ltd.
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-15
Decision date: 2021-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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