Clearance Summary
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit received FDA 510(k) clearance under submission number K172558, sponsored by Stryker Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-10-05.
- Submission: K172558
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2017-10-05
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.