510(k) K180327

Stryker iVAS 13g Bone Biopsy Kit by Stryker Corporation — Product Code KNW

K180327 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker iVAS 13g Bone Biopsy Kit". The FDA issued a decision of Substantially Equivalent on Feb 26, 2018. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Stryker Corporation has 80 other 510(k) clearances on record.