About This 510(k) Submission
K960400 is an FDA 510(k) clearance for the DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS), a Cannula And Trocar, Suprapubic, Non-disposable (Class I — General Controls, product code FBM), submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on March 12, 1996, 43 days after receiving the submission on January 29, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5090.