About This 510(k) Submission
K232826 is an FDA 510(k) clearance for the Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824), a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on March 8, 2024, 177 days after receiving the submission on September 13, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.