510(k) K233355

Cypris eXact Suturing System by Cypris Medical — Product Code GAW

K233355 is an FDA 510(k) premarket notification submitted by Cypris Medical for the device "Cypris eXact Suturing System". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Cypris Medical has at least 1 other 510(k) clearance on record.