510(k) K233265

Monotime and Optime R by Peters Surgical — Product Code GAM

K233265 is an FDA 510(k) premarket notification submitted by Peters Surgical for the device "Monotime and Optime R". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Peters Surgical has at least 6 other 510(k) clearances on record.