510(k) K152872— K2M Fenestrated Tap System

Substantially Equivalent

K2m

Clearance details

Applicant: K2m
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-30
Decision date: 2016-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, 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, 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.