ClearTip

FDA 510(k) K231267 · Finemedix Co., Ltd.

Substantially Equivalent

510(k) numberK231267

Submission

Device name
ClearTip
Applicant
Finemedix Co., Ltd.
Daegu, KR
Received
May 2, 2023
Decision date
June 30, 2023
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
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
K191472Biopsy NeedleFCG · Traditional Ushare Medical, Inc.01/29/2020SE

More from Ushare Medical, Inc.

510(k)DeviceDecision
K251478ClearTip TBNA TypeKTI · Traditional 04/16/2026SE
K250994ClearTip FNA and FNB TypesFCG · Traditional 08/21/2025SE
K242857ClearHemograsperKGE · Traditional 05/21/2025SE
K242134ClearCap Distal AttachmentOCX · Special 08/20/2024SE
K202616ClearCap Distal AttachmentOCX · Traditional 02/19/2021SE
K200217ClearEndoclipPKL · Traditional 10/05/2020SE
K183021ClearEndoclipPKL · Traditional 06/28/2019SE
K183289ClearGrasp SnareFDI · Traditional 03/06/2019SE
K181690Clear-Jet Injection CatheterFBK · Traditional 12/21/2018SE
K180363Clear-Tip EUS-FNAFCG · Traditional 11/01/2018SE

Questions and answers

When was ClearTip cleared by the FDA?

ClearTip (K231267) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 59 days after the submission was received.

What is the product code of K231267?

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