ISG VIEWING WAND— 510(k) K960714

Substantially Equivalent

I.S.G. Technologies, Inc.

FDA 510(k) clearance K960714 for ISG VIEWING WAND, Substantially Equivalent on 1996-05-29. Applicant: I.S.G. Technologies, Inc..

Clearance details

Applicant: I.S.G. Technologies, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1996-02-21
Decision date: 1996-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.