Product code FFO— Gastroenterology, Urology

FDA has cleared 5 devices under product code FFO between 1985 and 1999, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19991 clearance
• 19871 clearance
• 19861 clearance
• 19852 clearances

• Dantec Electronics, Inc.2 clearances
• The Kendal Co.1 clearance
• Sur-Med Instruments, Inc.1 clearance
• Advanced Surgical Concepts (Asc)1 clearance

• K993544 — SPACE-OR RETRACTORAdvanced Surgical Concepts (Asc)·1999-12-22
• K870897 — KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.·1987-06-04
• K860368 — URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.·1986-04-23
• K853119 — URODYN 1000Dantec Electronics, Inc.·1985-10-04
• K852083 — THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.·1985-09-20