INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL— 510(k) K081057

Substantially Equivalent

Intact Medical Corporation

FDA 510(k) clearance K081057 for INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL, Substantially Equivalent on 2008-06-17. Applicant: Intact Medical Corporation.

Clearance details

Applicant: Intact Medical Corporation
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2008-04-14
Decision date: 2008-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, 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.