COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015— 510(k) K082803
Substantially EquivalentPercutaneous Systems, Inc.
FDA 510(k) clearance K082803 for COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015, Substantially Equivalent on 2008-11-13. Applicant: Percutaneous Systems, Inc..
Clearance details
- Applicant
- Percutaneous Systems, Inc.
- Product code
- Code FFL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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, through . 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.