Cysto-Gastro-Sets— 510(k) K211909

Substantially Equivalent

G-Flex Europe Sprl

FDA 510(k) clearance K211909 for Cysto-Gastro-Sets, Substantially Equivalent on 2022-06-09. Applicant: G-Flex Europe Sprl.

Clearance details

Applicant: G-Flex Europe Sprl
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-21
Decision date: 2022-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nivelles, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.