Product code KAL— Ear, Nose, Throat

FDA has cleared 5 devices under product code KAL between 1977 and 1987, 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.

• 19871 clearance
• 19841 clearance
• 19782 clearances
• 19771 clearance

• Edward Weck, Inc.2 clearances
• V. Mueller O.V. Baxter Healthcare Corp.1 clearance
• Treace Medical, Inc.1 clearance
• Microtek Medical, Inc.1 clearance

• K870758 — SMALL MASTOID RETRACTORTreace Medical, Inc.·1987-03-04
• K833604 — ADJUSTABLE FORK RETRACTORMicrotek Medical, Inc.·1984-01-03
• K772381 — RING HANDLE & RETRACTORSEdward Weck, Inc.·1978-01-17
• K772392 — ALLPORT MASTOID RETRACTORSEdward Weck, Inc.·1978-01-17
• K760851 — CONVERSE ALTAR RETRACTORV. Mueller O.V. Baxter Healthcare Corp.·1977-03-10