510(k) K170811

Single Use Retrieval Nitinol Basket V by Olympus Medical Systems Corp. — Product Code LQR

K170811 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Retrieval Nitinol Basket V". The FDA issued a decision of Substantially Equivalent on November 27, 2017. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.