SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K120127) manufactured by Swan Valley Medical, Incorporated. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 2012. Regulation: 8.