Consulting Wallah › Device Explorer › Other devices › Suturing unit, single-use
Device Explorer · FDA GUDID · GMDN 57874

Suturing unit, single-use

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

US‑registered devices529in commercial distribution
Companies53labelers on GUDID
Single‑use85%of device records
Sterile82%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Arthrex, Inc.16531%
Biomet Orthopedics, Llc428%
Smith & Nephew, Inc.377%
T.A.G Medical Products Agricultural Cooperative Association306%
Lsi Solutions, Inc.285%
Conmed Corporation285%
Razek Equipamentos Ltda183%
Teleflex Incorporated173%

Top labelers

CompanyDevicesShare
Arthrex, Inc.16531%
Biomet Orthopedics, Llc428%
Smith & Nephew, Inc.377%
T.A.G Medical Products Agricultural Cooperative Association306%
Lsi Solutions, Inc.285%
Conmed Corporation285%
Razek Equipamentos Ltda183%
Teleflex Incorporated173%
Medos International Sàrl153%
Apollo Endosurgery, Inc.143%
Stryker Corporation92%
Applied Medical Technology, Inc.92%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SharpShooterChampion SlingShotSlingShotNanoPassSutureTOOLEasyPassExairArisDigitexTAPESendomina EZFuse systemendomina EZFuse sutureBirks Tying Forceps 110mm, 5mm Platform with 0.3CC-Hook RightCC-Hook LeftFlexPasser Tendon Retrieval Kit

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT113
HWQPASSER57
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE47
HWQPasser40
LXHOrthopedic manual surgical instrument30
HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING26

GMDN & GCC registration

  • GMDN code 57874 · non‑implantable
  • Single‑use 85% · sterile 82% · Rx‑only 85% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Angle (degree) · 16Length (Inch) · 16Outer Diameter (Millimeter) · 12Length (Centimeter) · 9Needle Gauge (Gauge) · 4Catheter Gauge (French) · 1

Use these as the dimensions to specify in a tender line.

How many suturing unit, single-use products are registered in the US?

529 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing unit, single-use", from 53 companies. The largest labeler is Arthrex, Inc. with 31% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HWQ (PASSER), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), HWQ (Passer)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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