Cleared Traditional

K233533 - NerveTape

K233533 is an FDA 510(k) clearance for NerveTape, manufactured by Biocircuit Technologies, Inc.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K233533 · Biocircuit Technologies, Inc. · Neurology device
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Feb 2024
Decision
102d
Days
Class 2
Risk

K233533 is an FDA 510(k) clearance for the NerveTape. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Biocircuit Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 12, 2024 after a review of 102 days - within the typical 510(k) review window.

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 Biocircuit Technologies, Inc. devices

FDA 510(k) Submission Details - K233533

510(k) Number K233533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2023
Decision Date February 12, 2024
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
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 Peers - JXI Cuff, Nerve

All 26
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K233533.
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024
Rebuilder Nerve Guidance Conduit
K230794 · Celestray Biotech Company, LLC., · Jan 2024
VersaWrap Nerve Protector
K232029 · Alafair Biosciences, Inc. · Nov 2023
Axoguard HA+ Nerve Protector (AGHA12)
K231708 · Axogen Corporation · Oct 2023