About This 510(k) Submission
K220292 is an FDA 510(k) clearance for the Disposable Endoscope Injection Needle, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on August 19, 2022, 199 days after receiving the submission on February 1, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.