Product code FFP— Gastroenterology, Urology

FDA has cleared 5 devices under product code FFP between 1983 and 1997, filed by 5 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.

• 19971 clearance
• 19902 clearances
• 19891 clearance
• 19831 clearance

• Telemed Systems, Inc.1 clearance
• Primrose Medical, Inc.1 clearance
• Mk Conquest Intl., Inc.1 clearance
• Inamed Development Co.1 clearance
• Cleveland Medical Supply & Services1 clearance

• K964634 — ANOKRYOMk Conquest Intl., Inc.·1997-06-06
• K901426 — COLONIC BALLOON DILATORTelemed Systems, Inc.·1990-06-21
• K894618 — INAMED RHEMO-D (TM) DILATORInamed Development Co.·1990-01-18
• K884713 — COLONIC BALLOON DIALATORSPrimrose Medical, Inc.·1989-09-29
• K830354 — COLORECTAL DILATORCleveland Medical Supply & Services·1983-05-27