Product code FYI— General, Plastic Surgery

FDA has cleared 4 devices under product code FYI between 1979 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
• 19831 clearance
• 19801 clearance
• 19791 clearance

• Surgical Technology Laboratories, Inc.1 clearance
• Omega Silicone, Inc.1 clearance
• ETHICON, Inc.1 clearance
• Conphar, Inc.1 clearance

• K871073 — OMEGA BIVALVE NASAL SPLINTSOmega Silicone, Inc.·1987-05-11
• K821178 — ETHICON EXTERNAL FIXATION WIREETHICON, Inc.·1983-06-11
• K801072 — STRAITH NASAL SPLINTSurgical Technology Laboratories, Inc.·1980-06-17
• K792106 — CONPHAR O.R. HEAD COVER-STERILEConphar, Inc.·1979-11-05