K222006

Substantially Equivalent

Sclerotherapy & Endoscopic Needles

Applicant: G-Flex Europe Sprl
Product code: FBK
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-07
Decision date: 2023-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nivelles, BE

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.