Cleared Traditional

K152967 - NERBRIDGE

K152967 is an FDA 510(k) clearance for NERBRIDGE, manufactured by Toyobo Co., Ltd.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K152967 · Toyobo Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
258d
Days
Class 2
Risk

K152967 is an FDA 510(k) clearance for the NERBRIDGE. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Toyobo Co., Ltd. (Kita-Ku, JP). The FDA issued a Cleared decision on June 22, 2016 after a review of 258 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.

FDA 510(k) Submission Details - K152967

510(k) Number K152967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2015
Decision Date June 22, 2016
Days to Decision 258 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
109d slower than avg
Panel avg: 149d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXI Device Classification - Class 2, Special Controls

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

Epstein Becker & Green, P.C.
James A. Boiani, MS, JD

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 K152967.
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated · Oct 2016
Nerve Capping Device
K152684 · Polyganics Innovations BV · Jan 2016
Reaxon Plus
K143711 · Medovent GmbH · Dec 2015
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
K152967 · NERBRIDGE
Download PDF FDA Summary Toyobo Co., Ltd.