JXS — Block, Cutting, Ent, Sterile Class I

FDA Device Classification

FDA product code JXS covers "Block, Cutting, Ent, Sterile", a Class I medical device regulated under 21 CFR 874.3540. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.