Product Code: JXI FDA class 2 21 CFR 882.5275

Cuff, Nerve

Neurology

Cuff, Nerve is a surgically implanted device placed around a peripheral nerve to deliver electrical stimulation or record neural signals for therapeutic or diagnostic purposes, with applications in pain management, neurological monitoring, and neuroprosthetics. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXI, regulated under 21 CFR 882.5275, and falls within the Neurology medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JXI in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JXI
Device Class: FDA class 2
Regulation Number: 882.5275
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260245	SILKBridge	Apr 09, 2026	Substantially Equivalent	KLISBio S.r.l.
K253363	NeuroSpan Bridge	Jan 17, 2026	Substantially Equivalent	Auxilium Biotechnologies, Inc.
K251505	VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)	Jul 22, 2025	Substantially Equivalent	Alafair Biosciences
K251175	VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)	Jul 17, 2025	Substantially Equivalent	Alafair Biosciences
K243889	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)	Apr 02, 2025	Substantially Equivalent	Orthocell, Ltd.
K242113	Nerve Wrap (07-DW-001-TAB)	Apr 02, 2025	Substantially Equivalent	Biocircuit Technologies, Inc.
K233322	Mochida Nerve Cuff	Jun 21, 2024	Substantially Equivalent	Mochida Pharmaceutical Co., Ltd.
K233533	NerveTape	Feb 12, 2024	Substantially Equivalent	Biocircuit Technologies, Inc.
K230794	Rebuilder Nerve Guidance Conduit	Jan 29, 2024	Substantially Equivalent	Celestray Biotech Company, LLC.,
K232029	VersaWrap Nerve Protector	Nov 02, 2023	Substantially Equivalent	Alafair Biosciences, Inc.
K231708	Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)	Oct 12, 2023	Substantially Equivalent	Axogen Corporation
K223640	Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)	Apr 07, 2023	Substantially Equivalent	Axogen Corporation
K210665	Nerve Tape	Jul 15, 2022	Substantially Equivalent	Biocircuit Technologies, Incorporated
K202234	NervAlign Nerve Cuff	Feb 10, 2022	Substantially Equivalent	Renerve, Ltd.
K201631	VersaWrap Nerve Protector	Sep 14, 2020	Substantially Equivalent	Alafair Biosciences, Inc.
K190246	NeuroShield	May 31, 2019	Substantially Equivalent	Monarch Bioimplants GmbH
K180222	Reaxon Plus	Apr 24, 2018	Substantially Equivalent	Medovent GmbH
K163446	AxoGen Nerve Cap	Aug 08, 2017	Substantially Equivalent	Axogen Corporation
K170656	Reinforced Flexible Collagen Nerve Cuff	Jun 01, 2017	Substantially Equivalent	Collagen Matrix, Inc.
K163457	NeuraGen 3D Nerve Guide Matrix	Jan 06, 2017	Substantially Equivalent	Integra LifeSciences Corporation
K162741	AxoGuard Nerve Connector	Oct 31, 2016	Substantially Equivalent	Cook Biotech Incorporated
K152967	NERBRIDGE	Jun 22, 2016	Substantially Equivalent	Toyobo Co., Ltd.
K152684	Nerve Capping Device	Jan 13, 2016	Substantially Equivalent	Polyganics Innovations BV
K143711	Reaxon Plus	Dec 02, 2015	Substantially Equivalent	Medovent GmbH
K130557	NEURAGEN 3D	Apr 24, 2014	Substantially Equivalent	Integra LifeSciences Corporation
K131541	FLEXIBLE COOAGEN NERVE CUFF	Apr 03, 2014	Substantially Equivalent	Collagen Matrix, Inc.
K132660	NERVE CUFF	Jan 10, 2014	Substantially Equivalent	Cook Biotech Incorporated
K103081	COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE	Mar 02, 2012	Substantially Equivalent	Biom'Up Sas
K112267	NEUROLAC(R) NERVE GUIDE	Oct 20, 2011	Substantially Equivalent	Polyganics B.V.,
K100382	SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331	Aug 05, 2010	Substantially Equivalent	Salumedica, LLC
K060952	COLLAGEN NERVE WRAP	Jul 14, 2006	Substantially Equivalent	Collagen Matrix, Inc.
K050573	NEUROLAC NERVE GUIDE	May 04, 2005	Substantially Equivalent	Polyganics B.V.,
K041620	NEURA WRAP NERVE PROTECTOR	Jul 16, 2004	Substantially Equivalent	Integra Lifesciences Corp.
K032115	NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03	Oct 10, 2003	Substantially Equivalent	Polyganics B.V.,
K031069	SURGISIS NERVE CUFF	May 15, 2003	Substantially Equivalent	Cook Biotech, Inc.
K012814	COLLAGEN NERVE CUFF	Sep 21, 2001	Substantially Equivalent	Collagen Matrix, Inc.
K011168	NEUROGEN NERVE GUIDE	Jun 22, 2001	Substantially Equivalent	Integra Lifesciences Corp.
K002098	SALUMEDICA NERVE CUFF	Nov 24, 2000	Substantially Equivalent	Salumedica, LLC
K983007	NEUROTUBE	Mar 22, 1999	Substantially Equivalent	Neuroregen, LLC
K850785	FASTUBE NERVE REGENERATION DEVICE	Jul 10, 1985	Substantially Equivalent	Research Medical, Inc.