510(k) K221591— Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

Substantially Equivalent

Schoelly Fiberoptic GmbH

Clearance details

Applicant: Schoelly Fiberoptic GmbH
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-02
Decision date: 2023-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denzlingen, DE

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.