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

Name: FDA 510(k) clearance K081057
Creator: U.S. Food and Drug Administration
Published: 2008-06-17

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. Device class: 2.

Clearance details

Applicant: Intact Medical Corporation
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
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 ↗

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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.