PENTAX Medical Video Colonoscope EC34-i10T Series— 510(k) K180285
Substantially EquivalentPentax Medical of America, Inc.
FDA 510(k) clearance K180285 for PENTAX Medical Video Colonoscope EC34-i10T Series, Substantially Equivalent on 2018-10-26. Applicant: Pentax Medical of America, Inc..
Clearance details
- Applicant
- Pentax Medical of America, Inc.
- Product code
- Code FDF
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Adverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
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.