About This 510(k) Submission
K230925 is an FDA 510(k) clearance for the Disposable Injection Needle AF series, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 27, 2023, 177 days after receiving the submission on April 3, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.