MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L— 510(k) K993568

Substantially Equivalent

Machida Endoscope Co., Ltd.

FDA 510(k) clearance K993568 for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L, Substantially Equivalent on 2000-03-13. Applicant: Machida Endoscope Co., Ltd..

Clearance details

Applicant: Machida Endoscope Co., Ltd.
Product code: Code GWG
Advisory panel: Neurology
Date received: 1999-10-21
Decision date: 2000-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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.