AxoGuard Nerve Connector

Cuff, Nerve

COOK BIOTECH INCORPORATED

The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Axoguard Nerve Connector.

Pre-market Notification Details

• Device ID: K162741
• 510k Number: K162741
• Device Name: AxoGuard Nerve Connector
• Classification: Cuff, Nerve
• Applicant: COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906
• Contact: Perry W. Guinn
• Correspondent: Katrina L. Molland; COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906
• Product Code: JXI
• CFR Regulation Number: 882.5275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-30
• Decision Date: 2016-10-31
• Summary: summary