K232028
Substantially EquivalentQ Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- Applicant
- Iq Endoscopes Limited
- Product code
- FDS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chepstow, GB
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.