510(k) K823916

WAX CURETTE TIP by Treace Medical, Inc. — Product Code JYG

K823916 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "WAX CURETTE TIP". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code JYG (Curette, Ear), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.