Cleared Special

Extended Reservoir; MiniMed Reservoir

K241622 · Medtronic Minimed · Chemistry
Jul 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K241622 is an FDA 510(k) clearance for the Extended Reservoir; MiniMed Reservoir, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on July 2, 2024, 27 days after receiving the submission on June 5, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K241622 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2024
Decision Date July 02, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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