Cleared Traditional

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

K241850 · Ulrich GmbH & Co. KG · General Hospital
Aug 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K241850 is an FDA 510(k) clearance for the ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180), a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on August 26, 2024, 60 days after receiving the submission on June 27, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K241850 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date August 26, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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