KCD — Bougie, Esophageal, Ent Class I

FDA Device Classification

FDA product code KCD covers "Bougie, Esophageal, Ent", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel. At least 3 recent 510(k) clearances have been granted under this product code.