Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)— 510(k) K232028

Substantially Equivalent

Iq Endoscopes Limited

FDA 510(k) clearance K232028 for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100), Substantially Equivalent on 2023-11-17. Applicant: Iq Endoscopes Limited.

Clearance details

Applicant: Iq Endoscopes Limited
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-07
Decision date: 2023-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chepstow, GB

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.