Product code FKN— Gastroenterology, Urology

FDA has cleared 4 devices under product code FKN between 1978 and 1989, filed by 2 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.

• 19892 clearances
• 19811 clearance
• 19781 clearance

• Quinton, Inc.2 clearances
• Akcess Medical Products, Inc.2 clearances

• K893478 — DA-16 AND DA-24 SHUNT ADAPTERSAkcess Medical Products, Inc.·1989-06-08
• K892667 — SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313Akcess Medical Products, Inc.·1989-05-04
• K813428 — SHUNT ADAPTERQuinton, Inc.·1981-12-31
• K771425 — A-V SHUNT EXTENSIONQuinton, Inc.·1978-01-03