Product code GCZ— General, Plastic Surgery

FDA has cleared 5 devices under product code GCZ 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.

• 19901 clearance
• 19891 clearance
• 19871 clearance
• 19811 clearance
• 19801 clearance

• Adept-Med Intl., Inc.3 clearances
• Jain Surgical Equipment, Inc.1 clearance
• Edward Weck, Inc.1 clearance

• K904536 — JAIN GRAFT ASSISTJain Surgical Equipment, Inc.·1990-11-29
• K893870 — ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.·1989-07-14
• K870809 — MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.·1987-03-19
• K802806 — VISECERA RETAINERAdept-Med Intl., Inc.·1981-01-23
• K801610 — CHILDREN'S HOSPITAL PEDIATRIC RETRACTOREdward Weck, Inc.·1980-08-04