Product code FJG— Gastroenterology, Urology

FDA has cleared 36 devices under product code FJG between 1977 and 1994, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19942 clearances
• 19922 clearances
• 19902 clearances
• 19862 clearances
• 19821 clearance
• 19818 clearances
• 19806 clearances
• 19796 clearances
• 19784 clearances
• 19773 clearances

• Gambro, Inc.7 clearances
• Hospal Medical Corp.4 clearances
• Extracorporeal Medical Specialities, Inc.4 clearances
• Cobe Laboratories, Inc.4 clearances
• Medical, Inc.3 clearances
• Cyberex Corp.3 clearances
• Travenol Laboratories, S.A.2 clearances
• Cobe Renal Care, Inc.2 clearances
• NIKKISO CO., LTD.1 clearance
• National Medical Care, Medical Products Div., Inc.1 clearance

• K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.·1994-09-07
• K933680 — GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.·1994-08-26
• K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.·1992-09-21
• K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.·1992-03-06
• K901368 — HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.·1990-08-02
• K902203 — TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.·1990-08-01
• K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NGambro, Inc.·1986-09-29
• K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZERGambro, Inc.·1986-01-08
• K820694 — COBE PPD 1.3L, #18-520-009Cobe Laboratories, Inc.·1982-03-31
• K812336 — COBE PPD 1.9Cobe Laboratories, Inc.·1981-08-31
• K811439 — EXP 200 PARALLEL PLATE DIALYZERExtracorporeal Medical Specialities, Inc.·1981-06-12
• K811440 — EXP 600 PARALLEL PLATE DIALYZERExtracorporeal Medical Specialities, Inc.·1981-06-12
• K810066 — COBE PPD .8Cobe Laboratories, Inc.·1981-06-09
• K810837 — CYBER 80 HEMODIALYZERCyberex Corp.·1981-05-05
• K802478 — CYBER 120 HEMODIALYZERCyberex Corp.·1981-03-20
• K803068 — NIKKISO ND-14 PARALLEL FLOW DIALYZERNIKKISO CO., LTD.·1981-03-04
• K802364 — EXTRACORPOREAL'S EXP 400 PARALLEL PLATEExtracorporeal Medical Specialities, Inc.·1981-01-29
• K802389 — GAMBRO LUNDIA PLATE DISP. DIALYZERGambro, Inc.·1980-12-22
• K801633 — THE BRAVO NEW PARALLEL FLOW DIALYZERBellco Artifidial Organ Spec., Inc.·1980-12-18
• K801451 — ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUMMedical, Inc.·1980-09-26
• K801377 — CYBER 120 HEMODIALYZERCyberex Corp.·1980-08-27
• K800424 — LUNDIA PLATE DISP.Gambro, Inc.·1980-04-10
• K792611 — GAMBRO LUNDIA PLATE DIALYZERGambro, Inc.·1980-02-06
• K791961 — EXTRACORPOREAL'S MODEL EX-85 DIALYZERExtracorporeal Medical Specialities, Inc.·1979-11-13
• K791448 — HEMODIALYZERS RP-510 AND RP-514Hospal Medical Corp.·1979-08-07
• K790758 — HEMOCLEAR U-NEPHROS 1.0 DIALYZERMedical, Inc.·1979-05-08
• K790533 — HD CAPILLARY FILM DIALYZER, MODEL 1001Travenol Laboratories, S.A.·1979-05-02
• K790001 — DIALYZER, MODEL F.M.D 150Hospal Medical Corp.·1979-03-06
• K781966 — DIALYZER, MAGNIFLO 100 PARALLEL PLATEErika, Inc.·1979-02-21
• K781795 — DIALYZER, PARALLEL FLOW DISPOSABLEMedical, Inc.·1978-12-15
• K780700 — LUNDIA PLATE DISPOSABLE DIALYZERGambro, Inc.·1978-07-17
• K780427 — RP-510/RP-514 PARALLEL PLATE DIALYZERSHospal Medical Corp.·1978-05-19
• K772318 — DIALYZER STANDARD, CODE 5DM1780Travenol Laboratories, S.A.·1978-01-26
• K771354 — PARALLEL PLATE DIALYZERSHospal Medical Corp.·1977-09-15
• K770858 — DIALYZER, ULTRADIFFUSER, DISPOSABLEGambro, Inc.·1977-06-14
• K770578 — PARALLEL PLATE DIALYZERCobe Laboratories, Inc.·1977-04-15