510(k) K220730

allFlex Ureteral Catheters, Krait Ureteral Catheters by Allwin Medical Devices, Inc. — Product Code KOD

K220730 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "allFlex Ureteral Catheters, Krait Ureteral Catheters". The FDA issued a decision of Substantially Equivalent on October 13, 2022. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Allwin Medical Devices, Inc. has at least 6 other 510(k) clearances on record.