Product code FKG— Gastroenterology, Urology

FDA has cleared 6 devices under product code FKG between 1979 and 1995, 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.

• 19951 clearance
• 19871 clearance
• 19841 clearance
• 19811 clearance
• 19792 clearances

• Professional Dialysis Products1 clearance
• Med-Pak Corp.1 clearance
• J.J. Skinner, Inc.1 clearance
• Dove Medical Supplies1 clearance
• Cutter Laboratories, Inc.1 clearance
• Argon Medical Corp.1 clearance

• K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KITJ.J. Skinner, Inc.·1995-05-03
• K871630 — KITS AND TRAYS FOR DIALYSIS USEDove Medical Supplies·1987-05-26
• K833780 — CAPD PREP KITProfessional Dialysis Products·1984-02-09
• K802361 — DIALYIS START CARE KITMed-Pak Corp.·1981-01-16
• K792207 — PERIDIAL PERITONEAL DIALYSIS TRAYCutter Laboratories, Inc.·1979-12-10
• K790353 — ACUTE RENAL DIALYSIS TRAYArgon Medical Corp.·1979-04-20