About This 510(k) Submission
K212860 is an FDA 510(k) clearance for the SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit), a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 7, 2021, 29 days after receiving the submission on September 8, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.