FDA.reportPublic FDA data

510(k) K213222

Device
Disposable Polypectomy Snare
Applicant
Beijing Zksk Technology Co., Ltd.
510(k) number
K213222
Product code
FDI
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-06
Date received
2021-09-29
Regulation
876.4300
Classification name
Snare, Flexible
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
Ma Li
Address
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle Economic Development Zone, Tongzho Beijing CN 101105 101105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251692Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd.2026-02-21
K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd.2023-03-03
K220846CORE-SNAREIncore Co., Ltd.2022-11-21
K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.2022-09-22
K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-27
K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)STERIS Corporation2021-10-07
K202478Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresBoston Scientific Corporation2020-10-08
K200745Lariat, Hot/Cold SnareUnited States Endoscopy Group, Inc.2020-04-21
K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy2019-11-22
K191048AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc.2019-07-18
K183289ClearGrasp SnareFinemedix Co., Ltd.2019-03-06
K182909Roth Net Retriever Product LineUnited States Endoscopy Group, Inc.2018-11-21
K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc.2018-08-24
K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd.2018-05-21
K172758Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd.2018-03-07