510(k) K210971— EnteraLoc Flow

Substantially Equivalent

Vonco Products

Clearance details

Applicant: Vonco Products
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-31
Decision date: 2021-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trevor, WI, US

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.