Echotip Ultra Ultrasound Needle

FDA 510(k) K083330 · Cook Endoscopy

Substantially Equivalent

510(k) numberK083330

Submission

Device name
Echotip Ultra Ultrasound Needle
Applicant
Cook Endoscopy
Winston-Salem, NC, US
Received
November 12, 2008
Decision date
February 6, 2009
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

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K250994ClearTip FNA and FNB TypesFCG · Traditional Finemedix Co., Ltd.08/21/2025SE
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
K212819Disposable Biopsy Refill NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional Cook Ireland, Ltd.05/20/2021SE

More from Cook Ireland, Ltd.

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K192697Instinct Plus Endoscopic Clipping DevicePKL · Traditional 03/05/2020SE
K090183Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special 09/25/2009SE
K061937Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional 12/01/2006SE

Questions and answers

When was Echotip Ultra Ultrasound Needle cleared by the FDA?

Echotip Ultra Ultrasound Needle (K083330) received a 510(k) decision of Substantially Equivalent on February 6, 2009, 86 days after the submission was received.

What is the product code of K083330?

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