FDA 510(k) Applications for Medical Device Product Code "FDI"
(Snare, Flexible)

FDA 510(k) Number Applicant Device Name Decision Date
K213222 Beijing ZKSK Technology Co.,Ltd Disposable Polypectomy Snare 06/06/2022
K140726 BOSTON SCIENTIFIC CORP. CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV 07/21/2014
K131700 BOSTON SCIENTIFIC CORP. SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES 11/04/2013
K133987 Boston Scientific Corporation CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES 01/24/2014
K202478 Boston Scientific Corporation Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares 10/08/2020
K160637 BOSTON SCIENTIFIC CORPORATION Rotatable Snares 03/30/2016
K091355 CONMED ENDOSCOPIC TECHNOLOGIES, INC. DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 07/22/2009
K050294 COOK IRELAND LTD COOK IRELAND SONNET POLYPECTOMY SNARE 03/31/2005
K123223 ENDOCHOICE, INC. EC SINGLE USE, POLYPECTOMY SNARE 01/10/2013
K152580 ENDOCHOICE, INC. rescuenet 11/03/2015
K073288 ETHICON ENDO-SURGERY, INC. ETHICON ENDO SURGERY ARTICULATING SNARE 06/12/2008
K183289 Finemedix Co., Ltd. ClearGrasp Snare 03/06/2019
K020891 GRANIT MEDICAL INNOVATIONS NAKAO SNARE II AND NAKAO SNARE III 06/17/2002
K172729 Hangzhou AGS MedTech CO., Ltd Polypectomy Snare 05/21/2018
K221713 Hangzhou AGS MedTech Co., Ltd. Polypectomy Snare 03/03/2023
K011667 HORIZONS INTL. CORP. HORIZONS INTERNATIONAL POLYPECTOMY SNARES 08/16/2001
K022268 HORIZONS INTL. CORP. HORIZONS REUSABLE POLYPECTOMY SNARES 10/25/2002
K083049 HORIZONS INTL. CORP. TORNADO ROTATABEL SNARE AND POLYP CATCHER 12/23/2008
K220846 Incore Co., Ltd. CORE-SNARE 11/21/2022
K992477 INSCOPE, LLC. ROTOSNARE 08/24/1999
K190512 Intelligent Endoscopy SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare 11/22/2019
K220089 Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Disposable Polyp Snare 09/22/2022
K960230 LIGHTHOUSE MEDICAL, INC. SNARE 07/31/1996
K142258 Medi-Globe Corporation PolyCatch Retrieval Device 09/30/2014
K150316 MICRO- TECH (NANJING) CO., LTD. Polypectomy Snare 07/30/2015
K971275 MILL-ROSE LABORATORY MILL-ROSE DISPOSABLE POLYPECTOMY SNARE 05/23/1997
K002927 ODON LIFETECHNOLOGY SNARE,FLEXIBLE 12/10/2000
K955650 OLYMPUS AMERICA, INC. OLYMPUS SD SERIES SNARES 03/29/1996
K172734 Olympus Medical Systems Corp. Single Use Electrosurgical Snare SD-400 12/07/2017
K140923 OVESCO ENDOSCOPY AG TRACTION POLYPECTOMY SNARE 11/18/2014
K212860 Steris Corporation SmartBand 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) 10/07/2021
K140763 UNITED STATES ENDOSCOPY MONOFILAMENT POLYPECTOMY SNARE 04/24/2014
K040961 UNITED STATES ENDOSCOPY GROUP, INC. INJECTOR NEEDLE/SNARE 07/08/2004
K970356 UNITED STATES ENDOSCOPY GROUP, INC. IRRIGATION/ASPIRATION POLYPECTOMY 03/25/1997
K151197 UNITED STATES ENDOSCOPY GROUP, INC. Lariat snare 07/06/2015
K200745 United States Endoscopy Group, Inc. Lariat, Hot/Cold Snare 04/21/2020
K133513 UNITED STATES ENDOSCOPY GROUP, INC. MULTI-STAGE SNARE 12/20/2013
K122462 UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET RETRIEVER 09/11/2012
K182909 United States Endoscopy Group, Inc. Roth Net Retriever Product Line 11/21/2018
K103611 UNITED STATES ENDOSCOPY GROUP, INC. UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION 05/09/2011
K173673 Wilson-Cook Medical, Inc AcuSnare Polypectomy Snare 08/24/2018
K191048 Wilson-Cook Medical, Inc. AcuSnare Polypectomy Snare - Duckbill 07/18/2019
K220790 Yangzhou Fartley Medical Instrument Technology Co., Ltd. Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare 06/27/2022
K172758 Zhejiang Chuangxiang Medical Technology Co., LTD. Rotatable Snares, Non-Rotatable Snares 03/07/2018


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