Product code FKY— Gastroenterology, Urology

FDA has cleared 4 devices under product code FKY between 1977 and 1999, filed by 4 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.

• 19991 clearance
• 19861 clearance
• 19831 clearance
• 19771 clearance

• Quinton, Inc.1 clearance
• Mercury Enterprises, Inc.1 clearance
• Dayspring Medical, Inc.1 clearance
• Abbott Laboratories1 clearance

• K991003 — PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLIDayspring Medical, Inc.·1999-06-09
• K862722 — TUBING CONNECTOR #10-810-60 100/PKG NON-STERILEMercury Enterprises, Inc.·1986-08-11
• K830002 — CAPD COLOR-GUARD SYSTEM PREPKITAbbott Laboratories·1983-03-11
• K771428 — TENCKHOFF PERITONEAL TUBING ADAPT.Quinton, Inc.·1977-10-18