Product code FKK— Gastroenterology, Urology

FDA has cleared 6 devices under product code FKK between 1980 and 1985, filed by 6 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.

• 19852 clearances
• 19841 clearance
• 19831 clearance
• 19821 clearance
• 19801 clearance

• Travenol Laboratories, S.A.1 clearance
• Rao Medical Devices, Inc.1 clearance
• Pollak (Intl.), Ltd.1 clearance
• Dyn-A-Med Products1 clearance
• Delmed, Inc.1 clearance
• American Medical Products, Inc.1 clearance

• K854512 — TUBING CLAMP CAT#1000-ARao Medical Devices, Inc.·1985-12-02
• K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SETTravenol Laboratories, S.A.·1985-12-02
• K844121 — CLAMP, TUBING, LINEDyn-A-Med Products·1984-12-17
• K831689 — EMPTY DIALYSATE CONTAINERDelmed, Inc.·1983-08-11
• K822551 — AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, Inc.·1982-10-13
• K802009 — FLOWCLAMP CAT.#1011 & 1012Pollak (Intl.), Ltd.·1980-10-31