Product code FIH— Gastroenterology, Urology

FDA has cleared 5 devices under product code FIH between 1988 and 1995, 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.

• 19951 clearance
• 19942 clearances
• 19901 clearance
• 19881 clearance

• Pharmacia Deltec, Inc.1 clearance
• L H M Ent., Inc.1 clearance
• Infusion Technology Intl.1 clearance
• E-Z-Em, Inc.1 clearance
• B&B Medical Assoc., Inc.1 clearance

• K932055 — PERCUPUMP IIE-Z-Em, Inc.·1995-03-21
• K931113 — CADD-TPN(TM) AMBULATORY INFUSION SYSTEMPharmacia Deltec, Inc.·1994-04-28
• K935461 — VECTOR AMBULATORY DRUG DELIVERY SYSTEMInfusion Technology Intl.·1994-04-28
• K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CCL H M Ent., Inc.·1990-02-15
• K881707 — INTROCULAR FLUID INJECTORB&B Medical Assoc., Inc.·1988-10-21