510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011168Substantially Equivalent

Neurogen Nerve Guide

Integra LifeSciences Corporation, Plainsboro NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011168 is the FDA 510(k) clearance record for NEUROGEN NERVE GUIDE, a class II device, cleared for Integra Lifesciences Corp. on under FDA product code JXI (Cuff, Nerve). FDA records list 94 510(k) clearances for Integra Lifesciences Corp., from to . As of , FDA records show 2 recalls naming K011168.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JXI Cuff, Nerve
Regulation
21 CFR 882.5275
Device class
Class II
Review panel
Neurology
Applicant
Integra Lifesciences Corp. 105 Morgan Ln., Plainsboro NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JXI

Trailing 12 months
2 clearances under product code JXI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260