Product code GYK— Neurology

FDA has cleared 13 devices under product code GYK between 1977 and 1996, filed by 8 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.

• 19961 clearance
• 19933 clearances
• 19891 clearance
• 19881 clearance
• 19872 clearances
• 19852 clearances
• 19841 clearance
• 19791 clearance
• 19771 clearance

• Holter-Hausner Intl.5 clearances
• Cordis Corp.2 clearances
• Radionics, Inc.1 clearance
• Pudenz-Schulte Medical Research Corp.1 clearance
• Cook, Inc.1 clearance
• Codman & Shurtleff, Inc.1 clearance
• Baxter Healthcare Corp1 clearance
• American V. Mueller1 clearance

• K962761 — REIGEL TUNNELING DEVICECook, Inc.·1996-10-11
• K934391 — V/P AND L/P CATHETER PASSERSRadionics, Inc.·1993-11-19
• K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPudenz-Schulte Medical Research Corp.·1993-09-10
• K932273 — CORDIS TUNNELERCordis Corp.·1993-08-23
• K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare Corp·1989-10-31
• K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.·1988-09-30
• K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROAmerican V. Mueller·1987-12-18
• K865075 — H-H SUBGALEAL TROCARHolter-Hausner Intl.·1987-01-13
• K853370 — H-H CATHETER PASSERS(TACL DESIGNHolter-Hausner Intl.·1985-09-18
• K853368 — H-H SHUNT INTRODUCERHolter-Hausner Intl.·1985-09-06
• K841553 — H-H SHUNT PASSERSHolter-Hausner Intl.·1984-05-14
• K792639 — H-H SHUNT INTRODUCERHolter-Hausner Intl.·1979-12-31
• K771529 — PERITONEAL INTRODUCER & SHEATHCordis Corp.·1977-08-16