510(k) K163620

Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves by Covidien — Product Code JOW

K163620 is an FDA 510(k) premarket notification submitted by Covidien for the device "Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves". The FDA issued a decision of Substantially Equivalent on Jan 19, 2017. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Covidien has 224 other 510(k) clearances on record.