TeesuVac Breast Biopsy Device Mark 1— 510(k) K212079

Substantially Equivalent

Teesuvac Aps

FDA 510(k) clearance K212079 for TeesuVac Breast Biopsy Device Mark 1, Substantially Equivalent on 2022-02-02. Applicant: Teesuvac Aps.

Clearance details

Applicant: Teesuvac Aps
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-02
Decision date: 2022-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoersholm, DK

Download summary PDF View on FDA.gov ↗

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, 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.