ASPIRATION/IRRIGATION CATHETER— 510(k) K961300

Name: FDA 510(k) clearance K961300
Creator: U.S. Food and Drug Administration
Published: 1996-06-07

Substantially Equivalent

Neuro Navigational Corp.

FDA 510(k) clearance K961300 for ASPIRATION/IRRIGATION CATHETER, Substantially Equivalent on 1996-06-07. Applicant: Neuro Navigational Corp.. Device class: 2.

Clearance details

Applicant: Neuro Navigational Corp.
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
Advisory panel: Neurology
Date received: 1996-04-04
Decision date: 1996-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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K965078 — 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS1997-03-06
K961406 — NEUROVIEW SCISSORS1996-06-13
K961173 — 1.2MM REUSABLE NEUROVIEW ENDOSCOPE1996-06-07
K960792 — DISPOSABLE NEUROVIEW INTRODUCER SHEATH1996-04-11
K954938 — DISPOSABLE NEUROVIEW OPERATING SHEATH1996-03-07

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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