ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG— 510(k) K896314
Substantially EquivalentHgm 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.. Device class: 2.
Clearance details
- Applicant
- Hgm Medical Laser Systems, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code GEX
view allMore clearances from Hgm Medical Laser Systems, Inc.
view allAdverse 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, through . 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.