Cohen-Warner Testicular Biopsy Tray 2N2720

Q: What is the product code of K844993?

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

FDA 510(k) K844993 · Omnis Surgical, Inc.

Substantially Equivalent

510(k) numberK844993

Submission

Device name: Cohen-Warner Testicular Biopsy Tray 2N2720
Applicant: Omnis Surgical, Inc.
Deerfield, IL, US
Received: December 26, 1984
Decision date: February 28, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K854518	Epidural Anesthesia TrayCAZ · Traditional	12/23/1985SE
K850979	Hemoconcentrator KitKDI · Traditional	07/29/1985SE
K843595	Cardiotomy Reservoir W/FilterDTN · Traditional	02/14/1985SE

Questions and answers

When was Cohen-Warner Testicular Biopsy Tray 2N2720 cleared by the FDA?

Cohen-Warner Testicular Biopsy Tray 2N2720 (K844993) received a 510(k) decision of Substantially Equivalent on February 28, 1985, 64 days after the submission was received.

What is the product code of K844993?

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