Cleared Traditional

NEURA WRAP NERVE PROTECTOR

K041620 · Integra Lifesciences Corp. · Neurology
Jul 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K041620 is an FDA 510(k) clearance for the NEURA WRAP NERVE PROTECTOR, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on July 16, 2004, 30 days after receiving the submission on June 16, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K041620 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2004
Decision Date July 16, 2004
Days to Decision 30 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

Similar Devices — JXI Cuff, Nerve

All 38
NeuroSpan Bridge
K253363 · Auxilium Biotechnologies, Inc. · Jan 2026
VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
K251505 · Alafair Biosciences · Jul 2025
VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
K251175 · Alafair Biosciences · Jul 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024