INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL is an FDA 510(k)-cleared medical device (K965040) manufactured by Johnson & Johnson Medical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 1997. Regulation: 8.