Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COLLAGEN NERVE CUFF

K-Number: K012814 · 2001-09-21

ApplicantCollagen Matrix, Inc.
Decision Date2001-09-21
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COLLAGEN NERVE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2001-09-21 under 510(k) number K012814. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN NERVE CUFF?

COLLAGEN NERVE CUFF is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K012814.

When did COLLAGEN NERVE CUFF receive FDA 510(k) clearance?

COLLAGEN NERVE CUFF received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012814.

Who is the listed applicant for COLLAGEN NERVE CUFF?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLAGEN NERVE CUFF?

The FDA product code for COLLAGEN NERVE CUFF is JXI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Collagen Matrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra Moldable

View all 41 devices →

Related Devices (Code: JXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK243889Remplir (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)Orthocell, Ltd.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑