NEUROGEN NERVE GUIDE— 510(k) K011168
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K011168 for NEUROGEN NERVE GUIDE, Substantially Equivalent on 2001-06-22. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plainsboro, NJ, US
Recent devices under product code JXI
view allMore clearances from Integra Lifesciences Corp.
view allRecalls naming K011168
K-number listed on FDA's recall record- Z-1470-2020 — NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
- Z-1287-2013 — NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011168.
Data sourced from openFDA. This site is unofficial and independent of the FDA.