Product code FII— Gastroenterology, Urology

FDA has cleared 5 devices under product code FII between 1982 and 2003, filed by 4 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.

• 20031 clearance
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19821 clearance

• Gambro, Inc.2 clearances
• Travenol Laboratories, S.A.1 clearance
• Nxstage Medical, Inc.1 clearance
• Hospal Medical Corp.1 clearance

• K030470 — NXSTAGE SYSTEM ONENxstage Medical, Inc.·2003-07-07
• K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10Gambro, Inc.·1988-08-24
• K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309Travenol Laboratories, S.A.·1987-10-13
• K862716 — HEMOFILTRATION SYSTEM 10Gambro, Inc.·1986-09-09
• K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPAHospal Medical Corp.·1982-10-06