510(k) K223300

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument by Geotek Medikal Ltd Sti — Product Code KNW

K223300 is an FDA 510(k) premarket notification submitted by Geotek Medikal Ltd Sti for the device "Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument". The FDA issued a decision of Substantially Equivalent on Apr 21, 2023. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Geotek Medikal Ltd Sti has 1 other 510(k) clearance on record.