Device Explorer · FDA GUDID · GMDN 17633

Urethrotome

"A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This ope

US‑registered devices129in commercial distribution
Companies15labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

National Advanced Endoscopy Devices, Inc.4938%
Stryker Corporation2419%
Grace Manufacturing, Inc.1512%
Sopro-Comeg Gmbh119%
Novo Surgical, Inc.65%
Richard Wolf Gmbh43%
Rz-Medizintechnik Gmbh43%
Karl Storz Gmbh & Co. Kg43%

Top labelers

CompanyDevicesShare
National Advanced Endoscopy Devices, Inc.4938%
Stryker Corporation2419%
Grace Manufacturing, Inc.1512%
Sopro-Comeg Gmbh119%
Novo Surgical, Inc.65%
Richard Wolf Gmbh43%
Rz-Medizintechnik Gmbh43%
Karl Storz Gmbh & Co. Kg43%
Medicon Eg. Chirurgiemechaniker-Genossenschaft32%
Mahe Medical Gmbh22%
Trokamed Gmbh22%
Steris Corporation22%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAUrethrotome cold-knife,straight 21Ch.TrokamedUrethrotomy knifeUrethrotomeE-LINEmahe medical GmbHRZ Medizintechnik GmbHn.a.MediconOlympusAEDNovo SurgicalMillenniumV. MuellerGreenwald Surgical Company, Inc.

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

FDA product codes

CodeNameDevices
EZOUrethrotome102
HIHHYSTEROSCOPE (AND ACCESSORIES)26
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL26
FAJCystoscope and accessories, flexible/rigid24
KQTEVACUATOR, GASTRO-UROLOGY24
FCLFORCEPS, BIOPSY, NON-ELECTRIC3

GMDN & GCC registration

  • GMDN code 17633 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 87% · 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

Length (Centimeter) · 3Length (Millimeter) · 3Angle (degree) · 2

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

No closely related category with 50+ devices.

How many urethrotome products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urethrotome", from 15 companies. The largest labeler is National Advanced Endoscopy Devices, Inc. with 38% of records.

Which FDA product codes apply?

EZO (Urethrotome), HIH (HYSTEROSCOPE (AND ACCESSORIES)), FAS (ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL), FAJ (Cystoscope and accessories, flexible/rigid)

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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