Product code FHS— Gastroenterology, Urology

FDA has cleared 12 devices under product code FHS between 1976 and 1981, filed by 5 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.

• 19812 clearances
• 19803 clearances
• 19791 clearance
• 19781 clearance
• 19773 clearances
• 19762 clearances

• Erika, Inc.6 clearances
• Travenol Laboratories, S.A.2 clearances
• Gambro, Inc.2 clearances
• Bentley Laboratories, Inc.1 clearance
• Bellco Artifidial Organ Spec., Inc.1 clearance

• K812811 — MICROCOIL 80 DIALYZERErika, Inc.·1981-12-03
• K811974 — MICROCOIL 150 DIALYZERErika, Inc.·1981-09-16
• K801634 — THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.·1980-12-17
• K800723 — MICRO-COIL 100 COIL DIALYZERErika, Inc.·1980-05-14
• K800174 — GAMBRO LUNDIA COIL DIALYZERGambro, Inc.·1980-02-13
• K790223 — DIALYZER, CD-800 COILTravenol Laboratories, S.A.·1979-03-26
• K781102 — DIALYZER, DISP., COIL, LUNDIAGambro, Inc.·1978-10-17
• K771349 — MODIFICATION TO KIDNEY DIALYZERErika, Inc.·1977-08-02
• K770735 — DIALYZER, COIL, CD, LSA, 5M1765Travenol Laboratories, S.A.·1977-05-10
• K761358 — COIL DIALYZER MODEL ALT 140Bentley Laboratories, Inc.·1977-01-10
• K760702 — ERI-FLO 900 DIALYZERErika, Inc.·1976-11-19
• K760374 — DIALYZER (MODEL 1850)Erika, Inc.·1976-10-27