510(k) K242228

Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) by Triopsy Medical, Inc. — Product Code KNW

K242228 is an FDA 510(k) premarket notification submitted by Triopsy Medical, Inc. for the device "Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.