Yag Laser 8000 Gastrointestinal Blee

Q: What is the product code of K840144?

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

FDA 510(k) K840144 · Cooper Medical Corp.

Substantially Equivalent

510(k) numberK840144

Submission

Device name: Yag Laser 8000 Gastrointestinal Blee
Applicant: Cooper Medical Corp.
Mchenry, IL, US
Received: January 13, 1984
Decision date: May 18, 1984
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
K833387	Argon Laser Surgical System 770 · Traditional	04/18/1984SE
K833497	Cooper Medical Model 770LLF · Traditional	04/17/1984SE
K832703	Argon Laser Sys-Model 5000HQE · Traditional	01/30/1984SE
K820261	Monitor CO2 Laser SystemHHR · Traditional	03/05/1982SE

Questions and answers

When was Yag Laser 8000 Gastrointestinal Blee cleared by the FDA?

Yag Laser 8000 Gastrointestinal Blee (K840144) received a 510(k) decision of Substantially Equivalent on May 18, 1984, 126 days after the submission was received.

What is the product code of K840144?

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