EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE— 510(k) K031789
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K031789 for EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE, Substantially Equivalent on 2003-08-08. Applicant: Pentax Precision Instrument Corp..
Clearance details
- Applicant
- Pentax Precision Instrument Corp.
- Product code
- Code ODG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Adverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
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.