Product code GZX— Neurology

FDA has cleared 13 devices under product code GZX between 1981 and 1993, filed by 9 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.

• 19932 clearances
• 19911 clearance
• 19891 clearance
• 19872 clearances
• 19861 clearance
• 19854 clearances
• 19831 clearance
• 19811 clearance

• Keeler Instruments, Inc.4 clearances
• Downs Surgical , Ltd.2 clearances
• Prothia USA, Inc.1 clearance
• O.R. Specialties, Inc.1 clearance
• Kinetic Medical Products1 clearance
• Cordis Corp.1 clearance
• Clarus Medical Systems, Inc.1 clearance
• American V. Mueller1 clearance
• American Russian Medical Services, Inc.1 clearance

• K932169 — MICROSURGICAL INSTRUMENTSAmerican Russian Medical Services, Inc.·1993-07-20
• K926048 — CLARUS ENDOSCOPIC BALL PROBEClarus Medical Systems, Inc.·1993-04-07
• K911932 — J105 JAMES SURGICAL SYSTEM I/A PACKO.R. Specialties, Inc.·1991-08-26
• K890216 — MICROSURGICAL KERATOMEKinetic Medical Products·1989-02-16
• K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUMDowns Surgical , Ltd.·1987-12-17
• K873934 — RANGE OF CROCODILE ACTION INSTRUMENTSDowns Surgical , Ltd.·1987-12-17
• K862971 — MICRA MICROSURGICAL INSTRUMENTSCordis Corp.·1986-08-25
• K853161 — THE VICKERS STANDARD MICROSURGERY SETKeeler Instruments, Inc.·1985-11-07
• K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HANDKeeler Instruments, Inc.·1985-11-07
• K853180 — VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDEDKeeler Instruments, Inc.·1985-10-28
• K853181 — VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDEDKeeler Instruments, Inc.·1985-10-28
• K831071 — UNIVERSAL INSTRU. SET FOR NEUROVASCULARProthia USA, Inc.·1983-06-08
• K810485 — DUJOVNY MICROSURGICAL SCISSORSAmerican V. Mueller·1981-02-27