Cleared Special

Rebellion; Phantom Multi-Bite Kerrison Rongeur

K221818 · Morpheus AG · Neurology
Oct 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K221818 is an FDA 510(k) clearance for the Rebellion; Phantom Multi-Bite Kerrison Rongeur, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Morpheus AG (Spaichingen, DE). The FDA issued a Cleared decision on October 7, 2022, 106 days after receiving the submission on June 23, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K221818 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date October 07, 2022
Days to Decision 106 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAE — Rongeur, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4840