FDA.reportPublic FDA data

510(k) K240192

Device
Single-use Extraction Baskets
Applicant
Scivita Medical Technology Co., Ltd.
510(k) number
K240192
Product code
LQR
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-15
Date received
2024-01-24
Regulation
876.5010
Classification name
Dislodger, Stone, Biliary
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
Wu Ruqin
Address
#2, Qingqiu St., Suzhou Industrial Park Suzhou CN 215000 215000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.2026-04-03
K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.2025-03-18
K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.2024-12-16
K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.2023-09-12
K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation2021-05-26
K201509Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd.2020-12-16
K191789Stonetome Stone Removal DeviceBoston Scientific Corporation2019-07-25
K182381Wilson-Cook Mini BasketWilson-Cook Medical, Inc.2018-10-30
K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction BasketWilson-Cook Medical, Inc.2018-03-28
K171915Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated2018-03-01
K173687Strange Bile Duct Stone Exploration SetCook Incorporated2017-12-15
K170898Wittich Nitinol Stone BasketCook Incorporated2017-12-12
K170811Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp.2017-11-27
K173009NCompass Nitinol Stone ExtractorsCook Incorporated2017-11-07
K131642RSH BILIARY STONE REMOVAL DEVICERsh, LLC2013-08-07