Bip-Coax-System

FDA 510(k) K915801 · Uni-Quatro Industries Canada, Inc.

Substantially Equivalent

510(k) numberK915801

Submission

Device name
Bip-Coax-System
Applicant
Uni-Quatro Industries Canada, Inc.
Niagara Falls, Ontario, CA
Received
December 24, 1991
Decision date
March 11, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FCG – Biopsy Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional Cook Ireland, Ltd.07/29/2024SE
K231422Precision GIFCG · Traditional Limaca Medical, Ltd.08/28/2023SE
K231267ClearTipFCG · Traditional Finemedix Co., Ltd.06/30/2023SE
K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional Cook Ireland, Ltd.05/30/2023SE
K212423EndoDrill® Model XFCG · Traditional Bibbinstruments AB03/29/2023SE
K212822Disposable Coaxial Biopsy NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
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K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional Cook Ireland, Ltd.05/20/2021SE

More from Cook Ireland, Ltd.

510(k)DeviceDecision
K905557CCC Crown-Core-Cut-NeedleKNW · Traditional 03/08/1991SE
K905556High Speed Core Cut Biopsy GunFCG · Traditional 03/08/1991SE

Questions and answers

When was Bip-Coax-System cleared by the FDA?

Bip-Coax-System (K915801) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 808 days after the submission was received.

What is the product code of K915801?

The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.