Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide

Q: What is the product code of K073399?

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

FDA 510(k) K073399 · Envisioneering, LLC

Substantially Equivalent

510(k) numberK073399

Submission

Device name: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide
Applicant: Envisioneering, LLC
St. Louis, MO, US
Received: December 4, 2007
Decision date: December 21, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 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
K041639	Targetscn Transrectal Ultrasound SystemIYO · Traditional	09/02/2004SE
K041638	Targetscan Biopsy KitITX · Traditional	09/02/2004SESK
K041637	Targetscan Transrectal Ultrasound SystemITX · Traditional	09/01/2004SE

Questions and answers

When was Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide cleared by the FDA?

Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide (K073399) received a 510(k) decision of Substantially Equivalent on December 21, 2007, 17 days after the submission was received.

What is the product code of K073399?

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