Cleared Traditional

Mochida Nerve Cuff

K233322 · Mochida Pharmaceutical Co., Ltd. · Neurology
Jun 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K233322 is an FDA 510(k) clearance for the Mochida Nerve Cuff, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Mochida Pharmaceutical Co., Ltd. (Shinjyuku-Ku, JP). The FDA issued a Cleared decision on June 21, 2024, 266 days after receiving the submission on September 29, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K233322 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date June 21, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXI — Cuff, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5275

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