510(k) K191315

Remington Medical, Inc. Automatic Cutting Needle (NAC) by Remington Medical, Inc. — Product Code KNW

K191315 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "Remington Medical, Inc. Automatic Cutting Needle (NAC)". The FDA issued a decision of Substantially Equivalent on July 12, 2019. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.