Product code FKW— Gastroenterology, Urology

FDA has cleared 3 devices under product code FKW between 1979 and 1989, filed by 3 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.

• 19891 clearance
• 19811 clearance
• 19791 clearance

• Vickers America Medical Corp.1 clearance
• Quinton, Inc.1 clearance
• Akcess Medical Products, Inc.1 clearance

• K893438 — T SERIES VESSEL TIPSAkcess Medical Products, Inc.·1989-06-08
• K810257 — VESSEL TIPS, SIZES 13-18Quinton, Inc.·1981-03-13
• K791645 — VICKERS MEDICAL MODEL 112 TREONIC DC2Vickers America Medical Corp.·1979-10-02