NEURA WRAP NERVE PROTECTOR— 510(k) K041620

Name: FDA 510(k) clearance K041620
Creator: U.S. Food and Drug Administration
Published: 2004-07-16

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K041620 for NEURA WRAP NERVE PROTECTOR, Substantially Equivalent on 2004-07-16. Applicant: Integra Lifesciences Corp.. Device class: 2.

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2004-06-16
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K041620

K-number listed on FDA's recall record

Z-1286-2013 — NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.Class II·Terminated·Integra LifeSciences Corporation·20130328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041620.

Data sourced from openFDA. This site is unofficial and independent of the FDA.