FDA.reportPublic FDA data

510(k) K250695

Device
Single-use Ureteral Access Sheath
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) number
K250695
Product code
FED
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-08
Date received
2025-03-07
Regulation
876.1500
Classification name
Endoscopic Access Overtube, Gastroenterology-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cathy Shi
Address
401, 501, Bldg. 4, Haizhi Technology Park, Fortis # 17 Bulan Rd.,Xialilang Community, Nanwan St. Shenzhen CN 518112 518112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FED#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260965CVAC Aspiration SystemCalyxo, Inc.2026-04-13
K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.2026-04-06
K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.2025-10-07
K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.2025-09-19
K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.2025-09-05
K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2025-07-03
K250585LumenaTM Ureteral Access SheathCathegenix (Xiamen) Co., Ltd.2025-06-27
K250452CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)MacroLux Medical Technology Co., Ltd.2025-06-02
K243710Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.2025-04-11
K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006Boston Scientific Corporation2025-03-21
K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250Dornier Medtech America2025-01-31
K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.2025-01-30
K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)Coloplast Corp.2024-11-12
K243091Over-tube (TR-1108A)Fujifilm Corporation2024-11-01
K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2024-10-08