510(k) K002546

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE by CIVCO Medical Instruments Co., Inc. — Product Code KNW

K002546 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE". The FDA issued a decision of Substantially Equivalent on October 31, 2000. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.