FDA.reportPublic FDA data

Suturing unit, reusable

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 reusable device.
GUDID devices
394
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00192896070134SUTURE CATCHER HOOK SONTEC INSTRUMENTS, INC.2800-74752018-09-07
00840343727543Gen2SURGIX MEDICAL LLCG2G372822026-04-22
00842180149984ELMED INCORPORATEDELMED INCORPORATED52213-002025-01-16
00842180152083ELMEDELMED INCORPORATED52203-012022-12-23
00842180152199ELMEDELMED INCORPORATED52205-61-062022-12-23
00842180152205ELMEDELMED INCORPORATED52205-61-092022-12-23
00842180158344ELMEDELMED INCORPORATEDRAF-KPL4 2023-01-27
00842180160095ELMEDELMED INCORPORATED52205-622023-01-23
00842180160187ELMEDELMED INCORPORATED52105-61-062023-01-23
00888867023833Arthrex®ARTHREX, INC.AR-1931S2018-09-28
00888867031418Arthrex®ARTHREX, INC.AR-4068-05SD2018-08-03
00888867044722Arthrex®ARTHREX, INC.AR-87012018-09-15
00888867044739Arthrex®ARTHREX, INC.AR-8701SR2018-08-03
00888867044746Arthrex®ARTHREX, INC.AR-87022018-08-03
00888867044753Arthrex®ARTHREX, INC.AR-87032018-08-03
00888867044760Arthrex®ARTHREX, INC.AR-87042018-08-03
00888867293212Arthrex®ARTHREX, INC.AR-10901F2025-03-12
00888867293236Arthrex®ARTHREX, INC.AR-10903F2025-03-12
00888867293243Arthrex®ARTHREX, INC.AR-10904F2025-03-12
00888867293298Arthrex®ARTHREX, INC.AR-10911F2025-03-12
00888867293304Arthrex®ARTHREX, INC.AR-10913F2025-03-12
00888867293328Arthrex®ARTHREX, INC.AR-10914F2025-03-12
00888867381490Arthrex®ARTHREX, INC.AR-10905F2025-03-12
00888867381506Arthrex®ARTHREX, INC.AR-10906F2025-03-12
00888867381513Arthrex®ARTHREX, INC.AR-10907F2025-03-12
00888867381520Arthrex®ARTHREX, INC.AR-10915F2025-03-12
00888867381537Arthrex®ARTHREX, INC.AR-10916F2025-03-12
00888867381544Arthrex®ARTHREX, INC.AR-10917F2025-03-12
00888867575097Arthrex®ARTHREX, INC.AR-13940HD2026-05-07
00888867575103Arthrex®ARTHREX, INC.AR-13940HDF2026-05-07
00888867575110Arthrex®ARTHREX, INC.AR-13942HD2026-05-07
00888867575127Arthrex®ARTHREX, INC.AR-13942HDF2026-05-07
00888867575134Arthrex®ARTHREX, INC.AR-13948HD2026-05-07
00888867575141Arthrex®ARTHREX, INC.AR-13948HDF2026-05-07
04058749025750NAFehling Instruments GmbH & Co. KGKCA-72026-04-22
04058749025774NAFehling Instruments GmbH & Co. KGKCB-82026-04-22
06438408007170Inion® Shoulder InstrumentationInion Oy12020-05-08
06438408007224Inion® Shoulder InstrumentationInion Oy12020-05-08
06438408007231Inion® Shoulder InstrumentationInion Oy12020-05-08
10381780213055Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONP2292017-10-31
10381780452096Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPM-2292018-02-26
10653405037576CONMEDConmed CorporationPCD102016-09-24
10810128462997Champion+ Suture PasserT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-600-0012026-04-07
10810128463000Champion+ Suture Passer T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION3910-600-0022026-04-07
10845854024256CONMEDConmed Corporation18.000152020-09-24
10845854031193CONCEPT, TRAMConmed CorporationC68002020-09-24
10845854031209CONCEPTConmed CorporationC68012020-09-24
10845854035702SUTURE SNAREConmed CorporationGU10032020-09-24
10845854035719RAVENConmed CorporationGU10042020-09-24
10845854035726RAVENConmed CorporationGU1004EL2020-09-24
10845854035733RAVENConmed CorporationGU10082020-09-24
10845854035740RAVENConmed CorporationGU1008EL2020-09-24
10850067560170LaproCloseSurgical Principals, IncLCLOSE-1002025-12-11
10850067560187LaproCloseSurgical Principals, IncLCLOSE-2002025-12-11
10850067560194LaproCloseSurgical Principals, IncLCLOSE-3002025-12-11
10884521678705VersaOneCovidien LPFCSPASS2017-09-14
14026704811547PILLINGTELEFLEX INCORPORATEDIPN0228832022-12-08
B390AR4068901Reprocessed SutureLasso, 90 Deg StraightSURETEK MEDICALAR-4068-902024-02-09
20653405037573CONMEDConmed CorporationPCD102016-09-24
00888867363779Arthrex®ARTHREX, INC.AR-7068-45XL2026-03-02
00888867363786Arthrex®ARTHREX, INC.AR-7068-70XL2026-03-02
00850075111039NativeINS ORTHO INC.203.0002026-02-26
00850075111046NativeINS ORTHO INC.403.0002026-02-26
00850075111077NativeINS ORTHO INC.206.0002026-02-26
54026704811545PILLINGTELEFLEX INCORPORATEDIPN0228832022-12-08
00198506088087ELMED INCORPORATEDELMED INCORPORATEDSTE52M4501 2026-01-23
00198506087387ELMED INCORPORATEDELMED INCORPORATEDSTE24070352026-01-07
00198506087455ELMED INCORPORATEDELMED INCORPORATED52225-732026-01-07
00850067560173LaproCloseSurgical Principals, IncLCLOSE-1002025-12-11
00850067560180LaproCloseSurgical Principals, IncLCLOSE-2002025-12-11
00850067560197LaproCloseSurgical Principals, IncLCLOSE-3002025-12-11
00198506086656ELMED INCORPORATEDELMED INCORPORATED52205-61-012025-11-25
00198506086755ELMED INCORPORATEDELMED INCORPORATED52205-61-05C2025-11-25
10818674026595Rotator Cuff GrasperT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION605900p2025-09-25
10810128462393Sliding Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION221200frv2025-09-14
10810128462409Tape CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION231220frv2025-09-14
10810128462416Cord CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION231200frv2025-09-14
10810128462423Knot Manipulator Full LoopT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION301200frv2025-09-14
10810128462430Combo GrasperT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION622200frv2025-09-14
10810128462447Switching StickT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION900120frv2025-09-14