Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices— 510(k) K201244
Substantially EquivalentTransmed7, LLC
FDA 510(k) clearance K201244 for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices, Substantially Equivalent on 2020-08-07. Applicant: Transmed7, LLC.
Clearance details
- Applicant
- Transmed7, LLC
- Product code
- Code KNW
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portola Valley, CA, US
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.