Cleared Traditional

K210665 - Nerve Tape (FDA 510(k) Clearance)

K210665 · Biocircuit Technologies, Incorporated · Neurology device
Jul 2022
Decision
497d
Days
Class 2
Risk

K210665 is an FDA 510(k) clearance for the Nerve Tape. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).

Submitted by Biocircuit Technologies, Incorporated (Atlanta, US). The FDA issued a Cleared decision on July 15, 2022, 497 days after receiving the submission on March 5, 2021.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K210665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date July 15, 2022
Days to Decision 497 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