NJU — Suture, Nonabsorbable, Nitinol Class II

FDA Device Classification

FDA product code NJU covers "Suture, Nonabsorbable, Nitinol", a Class II medical device regulated under 21 CFR 878.4495. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.