Product code GCE— General, Plastic Surgery

FDA has cleared 4 devices under product code GCE between 1980 and 1990, filed by 3 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.

• 19902 clearances
• 19861 clearance
• 19801 clearance

• Jeff Klein Surgical, Inc.2 clearances
• Quinton, Inc.1 clearance
• Mediflex Intl.1 clearance

• K901715 — KLEIN CORK(TM)Jeff Klein Surgical, Inc.·1990-05-11
• K901716 — KLEIN CONNECTOR(TM)Jeff Klein Surgical, Inc.·1990-05-11
• K855039 — MEDIFLEX INJECTION CAPMediflex Intl.·1986-01-24
• K801680 — BETA-CAP II ADAPTERQuinton, Inc.·1980-08-04