Cleared Traditional

K233322 - Mochida Nerve Cuff (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K233322 is an FDA 510(k) clearance for the Mochida Nerve Cuff. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Mochida Pharmaceutical Co., Ltd. (Shinjyuku-Ku, JP). The FDA issued a Cleared decision on June 21, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mochida Pharmaceutical Co., Ltd. devices

Submission Details

510(k) Number K233322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 148d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Kelliann H. Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JXI Cuff, Nerve

All 39
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K233322.
SILKBridge
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NeuroSpan Bridge
K253363 · Auxilium Biotechnologies, Inc. · Jan 2026
VersaCoat Nerve Protector (VTP-44G2)
K251505 · Alafair Biosciences · Jul 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · Alafair Biosciences · Jul 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025