Product code KCN— Ear, Nose, Throat

FDA has cleared 4 devices under product code KCN between 1979 and 2006, 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.

• 20061 clearance
• 19971 clearance
• 19931 clearance
• 19791 clearance

• Xomed, Inc.1 clearance
• Ultracell Medical Technologies, Inc.1 clearance
• Polyganics B.V.,1 clearance
• Invotec International, Inc.1 clearance

• K062540 — NASOPORE EAR, MODELS ND04, ND05Polyganics B.V.,·2006-10-18
• K973578 — INVOTEC EAR TAMPON (WICK) W/STRINGInvotec International, Inc.·1997-11-06
• K920357 — ULTRACELL EAR WICKUltracell Medical Technologies, Inc.·1993-02-01
• K791059 — POPE OTO-WICK, STERILE & NON-STERILEXomed, Inc.·1979-07-17