Cleared Traditional

Nerve Wrap (07-DW-001-TAB)

K242113 · Biocircuit Technologies, Inc. · Neurology

Apr 2025

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K242113 is an FDA 510(k) clearance for the Nerve Wrap (07-DW-001-TAB), a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Biocircuit Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on April 2, 2025, 257 days after receiving the submission on July 19, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number	K242113 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2024
Decision Date	April 02, 2025
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF