Promisemed Safety Huber Needles

K243332 is the FDA 510(k) clearance record for Promisemed Safety Huber Needles, a class II device, cleared for Promisemed Hangzhou Meditech Co., Ltd. on 2025-03-14 under FDA product code PTI (Non-Coring (Huber) Needle). FDA's definition for product code PTI reads: "The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums". FDA records list 35 510(k) clearances for Promisemed Hangzhou Meditech Co., Ltd., from 2017-05-11 to 2026-05-12. As of 2026-09-10, FDA records show no recalls naming K243332.