PENTAX Video Upper G.I. Scope EG34-i10— 510(k) K180292
Substantially EquivalentPentax Medical of America, Inc.
FDA 510(k) clearance K180292 for PENTAX Video Upper G.I. Scope EG34-i10, Substantially Equivalent on 2018-10-12. Applicant: Pentax Medical of America, Inc..
Clearance details
- Applicant
- Pentax Medical of America, Inc.
- Product code
- Code FDS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Adverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.