ELRAN 01 SYSTEM— 510(k) K002431
Substantially EquivalentEnvision Advanced Medical System, Ltd.
FDA 510(k) clearance K002431 for ELRAN 01 SYSTEM, Substantially Equivalent on 2000-10-24. Applicant: Envision Advanced Medical System, Ltd..
Clearance details
- Applicant
- Envision Advanced Medical System, Ltd.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Washington, DC, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.