PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System— 510(k) K213235
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K213235 for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System, Substantially Equivalent on 2022-12-21. Applicant: Pentax of America, Inc..
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code EOQ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.