Product code GAE— General, Plastic Surgery

FDA has cleared 4 devices under product code GAE between 1988 and 1995, 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.

• 19951 clearance
• 19931 clearance
• 19911 clearance
• 19881 clearance

• Acufex Microsurgical, Inc.2 clearances
• Cook Urological, Inc.1 clearance
• Advance Suture, Inc.1 clearance

• K950776 — BIPOLAR SNARECook Urological, Inc.·1995-04-18
• K926036 — ACUFEX SUTURE RETRIEVERAcufex Microsurgical, Inc.·1993-05-05
• K903174 — ADVANCE SUTURE ABSORBABLE GUT SUTUREAdvance Suture, Inc.·1991-07-10
• K881224 — ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEAcufex Microsurgical, Inc.·1988-06-01