About This 510(k) Submission
K120127 is an FDA 510(k) clearance for the SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM, a Catheter, Suprapubic (and Accessories) (Class II — Special Controls, product code KOB), submitted by Swan Valley Medical, Incorporated (Golden, US). The FDA issued a Cleared decision on October 26, 2012, 283 days after receiving the submission on January 17, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5090.