Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

Q: What is the product code of K181756?

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

FDA 510(k) K181756 · Apriomed AB

Substantially Equivalent

510(k) numberK181756

Submission

Device name: Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Applicant: Apriomed AB
Uppsala, SE
Received: July 2, 2018
Decision date: December 18, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code FCG

510(k)	Device	Applicant	Decision
K252646	Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional	Olympus Medical Systems Corp.	10/24/2025SE
K250994	ClearTip FNA and FNB TypesFCG · Traditional	Finemedix Co., Ltd.	08/21/2025SE
K241209	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional	Cook Ireland, Ltd.	07/29/2024SE
K231422	Precision GIFCG · Traditional	Limaca Medical, Ltd.	08/28/2023SE
K231267	ClearTipFCG · Traditional	Finemedix Co., Ltd.	06/30/2023SE
K230909	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional	Cook Ireland, Ltd.	05/30/2023SE
K212423	EndoDrill® Model XFCG · Traditional	Bibbinstruments AB	03/29/2023SE
K212822	Disposable Coaxial Biopsy NeedleFCG · Traditional	Suzhou Leapmed Healthcare Corporation	07/06/2022SE
K212819	Disposable Biopsy Refill NeedleFCG · Traditional	Suzhou Leapmed Healthcare Corporation	07/06/2022SE
K210476	EchoTip 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)	Device	Decision
K193268	APrioCore PlusKNW · Traditional	02/27/2020SE
K150625	Morrison Steerable NeedleKNW · Traditional	06/09/2015SE

Questions and answers

When was Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle cleared by the FDA?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (K181756) received a 510(k) decision of Substantially Equivalent on December 18, 2018, 169 days after the submission was received.

What is the product code of K181756?

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