Product code GDH— General, Plastic Surgery

FDA has cleared 6 devices under product code GDH between 1976 and 1990, 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.

• 19902 clearances
• 19891 clearance
• 19871 clearance
• 19841 clearance
• 19761 clearance

• United States Surgical, A Division of Tyco Healthc3 clearances
• Zinnanti Surgical Instruments, Inc.1 clearance
• V. Mueller O.V. Baxter Healthcare Corp.1 clearance
• Cher Mel Corp.1 clearance

• K903419 — MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVEUnited States Surgical, A Division of Tyco Healthc·1990-08-09
• K900487 — MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVEUnited States Surgical, A Division of Tyco Healthc·1990-02-09
• K891901 — GOUGES, ALEXANDER, BISHOP, LUCASZinnanti Surgical Instruments, Inc.·1989-04-12
• K874879 — AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVEUnited States Surgical, A Division of Tyco Healthc·1987-12-17
• K842822 — CHERMEL BONE GOUGESCher Mel Corp.·1984-08-02
• K760850 — PARKES HUMP GAUGE STRAIGHT 7 (18 CM)V. Mueller O.V. Baxter Healthcare Corp.·1976-11-03