Product code KAC— Ear, Nose, Throat

FDA has cleared 4 devices under product code KAC between 1981 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19901 clearance
• 19881 clearance
• 19821 clearance
• 19811 clearance

• Universal Prosthetics, Inc.1 clearance
• Shiley, Inc.1 clearance
• Portex, Inc.1 clearance
• Medical Innovations International, Inc.1 clearance

• K901377 — BARTON-MAYO TRACHEOSTOMA BUTTONMedical Innovations International, Inc.·1990-06-14
• K873992 — LARYNGECTOMY TUBEPortex, Inc.·1988-03-24
• K821993 — SHILEY LARYNGECTOMY TUBEShiley, Inc.·1982-08-12
• K811428 — NORTHWESTERN VOICE RESTORATION KITUniversal Prosthetics, Inc.·1981-06-16