Cleared Traditional

SQ.line KERRISON

K223596 · Aesculap, Inc. · Neurology
Jun 2023
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K223596 is an FDA 510(k) clearance for the SQ.line KERRISON, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on June 29, 2023, 209 days after receiving the submission on December 2, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K223596 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2022
Decision Date June 29, 2023
Days to Decision 209 days
Submission Type Traditional
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

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