Consulting Wallah › Device Explorer › Other devices › Suturing unit, reprocessed
Device Explorer · FDA GUDID · GMDN 61823

Suturing unit, reprocessed

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 devices272in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Provision19371%
Medline Industries, Inc.7126%
Suretek Medical73%
Stryker Sustainability Solutions, Inc.10%

Top labelers

CompanyDevicesShare
Provision19371%
Medline Industries, Inc.7126%
Suretek Medical73%
Stryker Sustainability Solutions, Inc.10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AAcumedToby OrthopaedicsTensorStrykerSmith and NephewProgressive Medical; Inc.Patient Positioning Solutions; Inc.Conmed/LinvatecBeatty Marketing and SalesArthrexDePuy MitekXirosConMedPatient Positioning Solutions, Inc.Progressive Medical, Inc.

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

FDA product codes

CodeNameDevices
HWQPasser153
HWQPASSER41
KDCInstrument, Surgical, Disposable20
LXHOrthopedic manual surgical instrument17
LXHOrthopedic Manual Surgical Instrument13
LHXTrousers, Anti-Shock5

GMDN & GCC registration

  • GMDN code 61823 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

No structured size data on the register.

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

How many suturing unit, reprocessed products are registered in the US?

272 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suturing unit, reprocessed", from 4 companies. The largest labeler is Provision with 71% of records.

Which FDA product codes apply?

HWQ (Passer), HWQ (PASSER), KDC (Instrument, Surgical, Disposable), LXH (Orthopedic manual surgical instrument)

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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