BRAIN PORT— 510(k) K120691

Clearance details

Applicant

Nico Corporation

Product code

Code GZT

Device class

Class 2

Regulation

21 CFR 882.4800

Advisory panel

Neurology

Date received

2012-03-07

Decision date

2012-06-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

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• Z-2200-2012 — 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.Class II·Terminated·Nico Corp.·20120717
• Z-2201-2012 — 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.Class II·Terminated·Nico Corp.·20120717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120691.