SmartPilot YpsoMate NS-A2.25— 510(k) K243901

Substantially Equivalent

Ypsomed AG

FDA 510(k) clearance K243901 for SmartPilot YpsoMate NS-A2.25, Substantially Equivalent on 2025-08-28. Applicant: Ypsomed AG. Device class: 2.

Clearance details

Applicant: Ypsomed AG
Product code: Code QOG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2024-12-19
Decision date: 2025-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burgdorf, CH

Download summary PDF View on FDA.gov ↗

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K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)2015-06-09

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