FDA.reportPublic FDA data

510(k) K260410

Device
Single Use Ureteral Access Sheath
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) number
K260410
Product code
FED
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-11
Date received
2026-02-09
Regulation
876.1500
Classification name
Endoscopic Access Overtube, Gastroenterology-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Haishao Wei
Address
Rm. 101-1, 201-1, 301, 401, Bldg. 50, #650 Hongfeng Rd. Donghu St., Linping District Hangzhou CN 311100 311100

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
K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.2026-09-21
K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.2026-09-18
K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation2026-08-04
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
K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.2025-07-08
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