Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set— 510(k) K170008

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K170008 for Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set, Substantially Equivalent on 2017-02-28. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2017-01-03
Decision date: 2017-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.