ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG— 510(k) K896314

Substantially Equivalent

Hgm Medical Laser Systems, Inc.

FDA 510(k) clearance K896314 for ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG, Substantially Equivalent on 1990-05-10. Applicant: Hgm Medical Laser Systems, Inc..

Clearance details

Applicant: Hgm Medical Laser Systems, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1989-11-01
Decision date: 1990-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.