Rondek PGA Suture (Beige or Violet)

Rondek PGA Suture (Beige or Violet) is an FDA 510(k)-cleared medical device (K180625) manufactured by Rk Manufacturing Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2018. Regulation: 8.