Product code KCJ— Ear, Nose, Throat

FDA has cleared 4 devices under product code KCJ between 1983 and 1992, 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.

• 19922 clearances
• 19891 clearance
• 19831 clearance

• Laparomed Corp.1 clearance
• Kells Medical, Inc.1 clearance
• Ethicon Endo-Surgery, Inc.1 clearance
• Apdyne Medical Co.1 clearance

• K923679 — ENDOPATH TISSUE RETAINING COMPONENTEthicon Endo-Surgery, Inc.·1992-09-09
• K921053 — LAPAROMED LIGATING LOOPLaparomed Corp.·1992-08-06
• K894369 — APDYNE PHENOL APPLICATOR KITApdyne Medical Co.·1989-10-12
• K832667 — LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.·1983-09-29