ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510— 510(k) K102887

Substantially Equivalent

Percutaneous Systems, Inc.

FDA 510(k) clearance K102887 for ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510, Substantially Equivalent on 2011-05-16. Applicant: Percutaneous Systems, Inc..

Clearance details

Applicant: Percutaneous Systems, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-30
Decision date: 2011-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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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.