INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM is an FDA 510(k)-cleared medical device (K992262) manufactured by Indigo Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 1999. Regulation: 8.