510(k) K261196

Promisemed VeriEcto Automatic Biopsy Needles by Promisemed Hangzhou Meditech Co., Ltd. — Product Code KNW

K261196 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed VeriEcto Automatic Biopsy Needles". The FDA issued a decision of Substantially Equivalent on May 12, 2026. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promisemed Hangzhou Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.