FDA 510(k) Premarket Notification K200745: Lariat, Hot/Cold Snare

Submission Details & Decision

Normalized public record details for 510(k) notification K200745.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K200745

Applicant / Sponsor

United States Endoscopy Group, Inc.

Device Name

Lariat, Hot/Cold Snare

Product Code

FDI

Decision Date

2020-04-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Special

Third Party Flag

Date Received

2020-03-23

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
COOK INCORPORATED Registration: 1000393132 View Registration
Wilson-Cook Medical Inc. Registration: 1037905 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
TeleMed Systems Registration: 1222168 View Registration
Conmed Corporation Registration: 1223925 View Registration
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
UNITED STATES ENDOSCOPY GROUP, INC. Registration: 1528319 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
DIVERSATEK HEALTHCARE INC Registration: 2183446 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
ASAHI INTECC (THAILAND) CO., LTD. Registration: 3003780911 View Registration
HOYA Corporation PENTAX Lifecare Division Registration: 3003782610 View Registration
HORIZONS INTL. CORP. Registration: 3004083736 View Registration
MEDI-GLOBE SRO Registration: 3004129994 View Registration
STERIS AST CZ s.r.o. Registration: 3004784537 View Registration
Micro-Tech (Nanjing) Co., Ltd. Registration: 3004837686 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
ALLWIN MEDICAL DEVICES, INC. Registration: 3005987240 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
OVESCO ENDOSCOPY AG Registration: 3006696607 View Registration
Consolidated Medical Equipment Company Registration: 3007305485 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
Olympus Vietnam Co. Ltd. Registration: 3008040402 View Registration
Ovesco Endoscopy USA Registration: 3008720584 View Registration
Eurofins STERIPAC GMBH Registration: 3009217531 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
Hangzhou AGS MedTech Co., Ltd. Registration: 3010288205 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
MEDI-GLOBE GMBH Registration: 3011146996 View Registration
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD Registration: 3011193403 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
FINEMEDIX Registration: 3012042439 View Registration
SANICURE BV Registration: 3012494290 View Registration
Micro-Tech (Nanjing) Co., Ltd. Registration: 3013440400 View Registration
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. Registration: 3013460719 View Registration
Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Registration: 3013526170 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
BEIJING ZKSK TECHNOLOGY CO., LTD. Registration: 3014620201 View Registration
Aomori Olympus Co., Ltd. Hirosaki Site Registration: 3014769442 View Registration
INCORE CO., LTD. Registration: 3017390965 View Registration
JIANA STERILIZATION TECHNOLOGY (HANGZHOU) CO., LTD Registration: 3021023752 View Registration
CHG-MERIDIAN CANADA LTD Registration: 3023102955 View Registration
AGS MEDTECH (THAILAND) CO., LTD. Registration: 3035434483 View Registration
OLYMPUS MEDICAL SYSTEMS CORP. Registration: 8010047 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
HOYA Corporation PENTAX Lifecare Division Registration: 9610877 View Registration
DIMEDA INSTRUMENTE GMBH Registration: 9611283 View Registration
AOMORI OLYMPUS CO., LTD. Kuroishi Site Registration: 9614641 View Registration
MEDI-GLOBE GMBH Registration: 9680809 View Registration
Boston Scientific Limited Registration: 9681260 View Registration

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