ENFit Adaptor— 510(k) K233190

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K233190 for ENFit Adaptor, Substantially Equivalent on 2024-01-18. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code PIO
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-28
Decision date: 2024-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

Download summary PDF View on FDA.gov ↗

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