PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U— 510(k) K203166
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K203166 for PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U, Substantially Equivalent on 2020-12-30. Applicant: Pentax of America, Inc..
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code ODG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Montvale, NJ, 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.