FDA.report

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
201
Last updated
2026-03-27 18:10:20

Related Product Codes

CodeDeviceSpecialtyClassDevices
LXHOrthopedic Manual Surgical InstrumentOrthopedic158
HWQPasserOrthopedic152
NBHAccessories, ArthroscopicOrthopedic118
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology212
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology211
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery110
DWSInstruments, Surgical, CardiovascularCardiovascular18
QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight LossGastroenterology, Urology28
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic24
GEJCarrier, LigatureGeneral, Plastic Surgery13
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery13
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery22
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery12
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery12
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery11
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery11
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery11
HRXArthroscopeOrthopedic21
HXIPasser, Wire, OrthopedicOrthopedic11
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery11
PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ ProlapseObstetrics/Gynecology21
SBKArtificial Chordae Tendineae Surgical Replacement SystemCardiovascular21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
05425029282599endomina EZFuse systemEndo Tools Therapeuticsendomina EZFuse system2026-03-19
05425029282643endomina EZFuse sutureEndo Tools Therapeuticsendomina EZFuse suture2026-03-19
00850075111091NativeINS ORTHO INC.416.0002026-02-26
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION05.06.10.00222026-02-09
18022057015867TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLMI-COTIE-0012026-02-03
18022057015874JOSEPH LAMELAS Knot PusherCORCYM SRLMI-KP-0012026-02-03
07350154050004SutureTOOLSuturion ABBOM 1018S rev 10 SutureTOOL2025-12-15
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONM005054102025-09-19
00810155330668Tigon MedicalTigon Medical LLCTIGO PRO 0082025-08-18
00854288008315Tigon MedicalTigon Medical LLCTIGO PRO 0062025-08-18
00854288008339Tigon MedicalTigon Medical LLCTIGO PRO 0082025-08-18
00854288008346Tigon MedicalTigon Medical LLCTIGO PRO 0092025-08-18
00888867480568Arthrex®ARTHREX, INC.AR-78412025-08-08
00888867480575Arthrex®ARTHREX, INC.AR-78422025-08-08
00888867480582Arthrex®ARTHREX, INC.AR-78432025-08-08
00888867480599Arthrex®ARTHREX, INC.AR-7844L2025-08-08
00888867480605Arthrex®ARTHREX, INC.AR-7844R2025-08-08
00194613118488MSI Precision Specialty InstrumentsMed Saver, Inc.B2711N2025-08-01
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONM005054602025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONM005054902025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONM005054302025-07-28
00888867458574Arthrex®ARTHREX, INC.AR-1249IB-12025-07-23
00888867458598Arthrex®ARTHREX, INC.AR-1254IB-12025-07-23
10888867458588Arthrex®ARTHREX, INC.AR-1249IB2025-07-23
10888867458601Arthrex®ARTHREX, INC.AR-1254IB2025-07-23
10850012846434PicoDriverLSI Solutions, Inc.0232682025-07-19
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7952025-05-28
10810128461150Champion®+ Slider Handle, DisposableT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7702025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7682025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7672025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7662025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7652025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7642025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7632025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-500-7622025-05-28
00842071149406RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-S-072025-05-06
00842071149437RHAPSOAPPLIED MEDICAL TECHNOLOGY, INC.ESD110-C-072025-05-06
00816342025553ProPassPARCUS MEDICAL LLC116792025-04-29
00842071148980GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221-S-072025-03-07
00842071149017GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221-C-072025-03-07
00842071147303GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.ES4-8000-012024-11-27
00812608022304PMIPROGRESSIVE MEDICAL, INC.PMICC5122024-11-12
00812608022335PMIPROGRESSIVE MEDICAL, INC.PMICC512S2024-11-12
00812608022359PMIPROGRESSIVE MEDICAL, INC.PMICCXLKT2024-11-12
08714729838005Capio SLIMBOSTON SCIENTIFIC CORPORATIONM00683182502016-09-24
07898994583400RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7419600002024-11-04
07898994583431RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426700002024-11-04
07898994583448RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426600002024-11-04
07898994583455RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426500002024-11-04
07898994583462RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426400002024-11-04
07898994583479RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426200002024-11-04
07898994583486RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426100002024-11-04
07898994583493RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7424200002024-11-04
07908832500008RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7420100002024-11-04
07908832500015RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7420000002024-11-04
07908832500022RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7419900002024-11-04
07908832500039RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7419800002024-11-04
07908832500046RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7419700002024-11-04
07908832500053RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7427100002024-11-04
07908832500060RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7427200002024-11-04
07908832528156RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA9788511402024-10-29
10850200006497SEW-EASY®LSI Solutions, Inc.0227972024-10-21
10850200006503SEW-EASY®LSI Solutions, Inc.0222002024-10-21
10850200006510SEW-EASY®LSI Solutions, Inc.0228042024-10-21
10850200006527SEW-EASY®LSI Solutions, Inc.0222012024-10-21
00842071144975GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221S-072024-10-04
00842071145002GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.ESD221C-072024-10-04
00811955020834OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.ESS-ESG-NXT2024-10-01
10850012846045Mi-CHORD™LSI Solutions, Inc.0321502024-07-12
00854037007170eXact Suture Placement DeviceCypris Medical, Inc.CM30612024-06-10
10858733006007JOSEPH LAMELAS Knot PusherBiorep Technologies, Inc.8.02024-04-23
10858733006038COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary MuscleBiorep Technologies, Inc.7.02024-04-23
05060267134011CC-Hook LeftXIROS LTD202-14112024-04-25
05060267134028CC-Hook RightXIROS LTD202-14132024-04-25
24026704924312WECKTELEFLEX INCORPORATEDIPN9293722024-03-29
10850012846281VIRTUOSEW™LSI Solutions, Inc.0230502024-02-14
07898994583417RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7427000002024-01-25
07898994583424RAZEK EQUIPAMENTOSRAZEK EQUIPAMENTOS LTDA7426800002024-01-25
10630094490820Bioseal Inc.BIOSEAL4908/242024-01-24
00811955020896OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.ESS-G02-NXT2023-11-16