K251562

Substantially Equivalent

OTSCneo System Set (100.03n-14n, 100.27n-31n)

Applicant: Ovesco Endoscopy AG
Product code: PKL
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-22
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuebingen, DE

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.