FDA.reportPublic FDA data

Suturing unit, single-use

Definition
A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
GUDID devices
375
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630094490823Bioseal Inc.BIOSEAL4908/242024-01-24
00811955020827Apollo 2-0 Polypropylene Endobariatric SutureApollo Endosurgery, Inc.PLY-G02-020-BAR2023-01-10
00811955020919NXT Tissue Helix ProApollo Endosurgery, Inc.NXT-THXP-130 2023-11-16
00812608021055PMIPROGRESSIVE MEDICAL, INC.PMITCSG2016-09-23
00812608022052PMIPROGRESSIVE MEDICAL, INC.PMITCSGXL2020-03-12
00812608022328PMIPROGRESSIVE MEDICAL, INC.PMICC512S2024-11-12
00812608022342PMIPROGRESSIVE MEDICAL, INC.PMICCXLKT2024-11-12
00827002351196NovapassCOOK INCORPORATEDG351192020-10-02
00840113230518Hoffee Suture RetrieverASPEN SURGICAL PRODUCTS, INC.7100002021-03-22
00840113230525Hoffee Suture RetrieverASPEN SURGICAL PRODUCTS, INC.710000NS2021-03-22
00840113230532Green Genie Suture PasserASPEN SURGICAL PRODUCTS, INC.7100012021-03-22
00842071144968GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221S-072024-10-04
00842071144999GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221C-072024-10-04
00842071147297GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.ES4-8000-012024-11-27
00842071148973GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221-S-072025-03-07
00842071149000GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221-C-072025-03-07
00842071149390RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-S-072025-05-06
00842071149420RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-C-072025-05-06
00842071151119RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-S-072026-03-25
00842071151140RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-C-072026-03-25
00842102105043RSG-14F-4FLEXBAR MACHINE CORPORATIOND10012016-11-11
00842102105098Mediflex Suture PassersFLEXBAR MACHINE CORPORATIOND20012017-02-22
00842102105104Mediflex Suture PassersFLEXBAR MACHINE CORPORATIOND1001-C2017-02-22
00850009417213M-Close KitNew Wave Endo-Surgery Inc.27-1082020-09-21
00850012846048Mi-CHORD™LSI Solutions, Inc.0321502024-07-12
00850012846239MD™ MATTRESS DEVICELSI Solutions, Inc.0231502025-10-09
00850012846284VIRTUOSEW™LSI Solutions, Inc.0230502024-02-14
00850012846437PicoDriverLSI Solutions, Inc.0232682025-07-19
00850012846703PicoDriverLSI Solutions, Inc.0234702026-04-28
00850028211465GoldenDentGoldenDentSPGA32021-02-25
00850028211472GoldenDentGoldenDentSPGA42021-02-25
00850075111107NativeINS ORTHO INC.416.0002026-02-26
00850200006117RD® - THE RUNNING DEVICE®LSI Solutions, Inc.0210002016-09-23
00850200006124RD® - THE RUNNING DEVICE®LSI Solutions, Inc.0210212016-09-23
00850200006131RD180® - THE RUNNING DEVICE®LSI Solutions, Inc.0211002016-09-23
00850200006155RD180® - THE RUNNING DEVICE®LSI Solutions, Inc.0213302016-09-23
00850200006209RD180® SP™LSI Solutions, Inc.0214502016-09-23
00850200006308C1® DEVICELSI Solutions, Inc.0220002016-09-23
00850200006490SEW-EASY®LSI Solutions, Inc.0227972024-10-21
00850200006506SEW-EASY®LSI Solutions, Inc.0222002024-10-21
00850200006513SEW-EASY®LSI Solutions, Inc.0228042024-10-21
00850200006520SEW-EASY®LSI Solutions, Inc.0222012024-10-21
00850200006544SEW-EASY®LSI Solutions, Inc.0220502020-03-13
00850200006612C1® DEVICELSI Solutions, Inc.0226002020-03-13
00850200006636SEW-EASY®LSI Solutions, Inc.0227972020-03-13
00850200006643SEW-EASY®LSI Solutions, Inc.0228042020-03-13
00850200006650SEW-EASY®LSI Solutions, Inc.0228112020-03-13
00850200006667RAM®LSI Solutions, Inc.0225802020-03-13
00850200006674RAM®LSI Solutions, Inc.0219002020-03-13
00850200006711SEW-EASY®LSI Solutions, Inc.0222002020-03-13
00850200006728SEW-EASY®LSI Solutions, Inc.0222012020-03-13
00850200006735SEW-EASY®LSI Solutions, Inc.0221602020-03-13
00850200006889SEW-EASY®LSI Solutions, Inc.0225402020-03-13
00857878007002SUTURE GRASPER, 14GA #0013838RANFAC CORP.15CM X 14GA2017-08-24
00857878007804RSG-14RANFAC CORP.RSG-142019-06-19
00858690006273RSG-14-13, F/G #0002272RANFAC CORP.15CM x 14 GA2017-05-09
00858690006785RSG-14RANFAC CORP.14 GAUGE X 15CM2017-05-04
00858733006000JOSEPH LAMELAS Knot PusherBiorep Technologies, Inc.8.02024-04-23
00858733006031COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary MuscleBiorep Technologies, Inc.7.02024-04-23
00860007711206EasyWhipWinter Innovations Inc.EW-01-12021-11-18
00880304568440EZ PASSBiomet Orthopedics, LLC1100085882020-05-20
00880304568457EZ PASSBiomet Orthopedics, LLC1100085892020-05-20
00880304568464EZ PASSBiomet Orthopedics, LLC1100085902020-05-20
00880304568471EZ PASSBiomet Orthopedics, LLC1100085912020-05-20
00880304568488EZ PASSBiomet Orthopedics, LLC1100085922020-05-20
00880304568495EZ PASSBiomet Orthopedics, LLC1100085932020-05-20
00880304568501EZ PASSBiomet Orthopedics, LLC1100085942020-05-20
00888867038882Arthrex®ARTHREX, INC.AR-6068-012018-08-03
00888867056855Arthrex®ARTHREX, INC.AR-8999N2018-10-04
00888867189362Arthrex®ARTHREX, INC.AR-16991N2018-08-03
00888867219557Arthrex®ARTHREX, INC.AR-16992N2018-10-04
00888867281547Arthrex®ARTHREX, INC.AR-78162018-09-15
00888867439054Arthrex®ARTHREX, INC.AR-2252D2024-01-09
00888867458581Arthrex®ARTHREX, INC.AR-1249IB2025-07-23
00888867458604Arthrex®ARTHREX, INC.AR-1254IB2025-07-23
00888937002942Carter-Thomason Coopersurgical, Inc.CTI-SP2016-08-19
00888937002959Carter-ThomasonCoopersurgical, Inc.CTSG2016-08-19
03596010025043NASmith & Nephew, Inc.0135932015-08-30
03596010026026TRANSPORTERSmith & Nephew, Inc.0146172015-08-30
03596010036117NASmith & Nephew, Inc.1106752015-08-29