Product code FIL— Gastroenterology, Urology

FDA has cleared 8 devices under product code FIL between 1977 and 2002, filed by 7 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.

• 20021 clearance
• 19901 clearance
• 19891 clearance
• 19791 clearance
• 19781 clearance
• 19773 clearances

• Travenol Laboratories, S.A.2 clearances
• Hemametrics1 clearance
• Gambro, Inc.1 clearance
• Fresenius USA, Inc.1 clearance
• Extracorporeal Medical Specialities, Inc.1 clearance
• Cyberex Corp.1 clearance
• Baxter Healthcare Corp1 clearance

• K011741 — CRIT-LINE MONITOR III TQA (CLM TQA)Hemametrics·2002-07-23
• K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION)Baxter Healthcare Corp·1990-04-19
• K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEMFresenius USA, Inc.·1989-05-11
• K790824 — REPGREEN ULTRAFILTRATION MONITORCyberex Corp.·1979-06-27
• K781633 — ULTRAFILTRATION SCALEExtracorporeal Medical Specialities, Inc.·1978-12-07
• K771875 — ULTRAFILTRATION MONITOR 5M9034Travenol Laboratories, S.A.·1977-11-30
• K771227 — AK-10Gambro, Inc.·1977-08-02
• K770137 — NEGATIVE PRESSURE ADAPTER 5M1350Travenol Laboratories, S.A.·1977-02-01