SUREcore Plus Biopsy Instrument— 510(k) K220611

Substantially Equivalent

Uro-1, Inc.

FDA 510(k) clearance K220611 for SUREcore Plus Biopsy Instrument, Substantially Equivalent on 2022-12-02. Applicant: Uro-1, Inc..

Clearance details

Applicant: Uro-1, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-03
Decision date: 2022-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, US

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.