ACCORDION— 510(k) K052048

Substantially Equivalent

Percutaneous Systems, Incorporated

FDA 510(k) clearance K052048 for ACCORDION, Substantially Equivalent on 2005-09-13. Applicant: Percutaneous Systems, Incorporated.

Clearance details

Applicant: Percutaneous Systems, Incorporated
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 2005-07-29
Decision date: 2005-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.