PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope— 510(k) K181522
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K181522 for PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope, Substantially Equivalent on 2018-07-09. Applicant: Pentax of America, Inc..
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code FDT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Montvale, NJ, US
Adverse events under product code FDT
product code FDT- Death
- 86
- Injury
- 1,954
- Malfunction
- 14,912
- Total
- 16,952
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.