Sonopsy

FDA 510(k) K013109 · Hakko Medical Co., Ltd.

Substantially Equivalent

510(k) numberK013109

Submission

Device name
Sonopsy
Applicant
Hakko Medical Co., Ltd.
Meguro-Ku, Tokyo, JP
Received
September 17, 2001
Decision date
March 12, 2002
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)DeviceApplicantDecision
K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional Olympus Medical Systems Corp.10/24/2025SE
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.

510(k)DeviceDecision
K030824Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,MODEL LD112GCJ · Traditional 06/04/2003SE
K013108BiosucKNW · Traditional 04/04/2002SE

Questions and answers

When was Sonopsy cleared by the FDA?

Sonopsy (K013109) received a 510(k) decision of Substantially Equivalent on March 12, 2002, 176 days after the submission was received.

What is the product code of K013109?

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