About This 510(k) Submission
K960574 is an FDA 510(k) clearance for the ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM, a Pneumoperitoneum Needle (Class II — Special Controls, product code FHO), submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on August 5, 1996, 175 days after receiving the submission on February 12, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.