iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit— 510(k) K172558

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K172558 for iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit, Substantially Equivalent on 2017-10-05. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2017-08-24
Decision date: 2017-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, 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.