AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON— 510(k) K163424
Substantially EquivalentUnited State Endoscopy Group, Inc.
FDA 510(k) clearance K163424 for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON, Substantially Equivalent on 2017-01-04. Applicant: United State Endoscopy Group, Inc..
Clearance details
- Applicant
- United State Endoscopy Group, Inc.
- Product code
- Code FEQ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Adverse events under product code FEQ
product code FEQ- Malfunction
- 1,135
- Total
- 1,135
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.