K231323

Substantially Equivalent

Ancora-SB

Applicant: Aspero Medical, Inc.
Product code: FDA
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-08
Decision date: 2023-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Collins, CO, US

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.