Device Explorer · FDA GUDID · GMDN 35301

Resectoscope

An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign

US‑registered devices171in commercial distribution
Companies12labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Rz-Medizintechnik Gmbh4929%
National Advanced Endoscopy Devices, Inc.4929%
American Medical Endoscopy, Inc.2414%
Richard Wolf Gmbh1811%
Gyrus Acmi, Llc106%
Mahe Medical Gmbh64%
Aulea Medical Inc.64%
Hermann Medizintechnik Gmbh42%

Top labelers

CompanyDevicesShare
Rz-Medizintechnik Gmbh4929%
National Advanced Endoscopy Devices, Inc.4929%
American Medical Endoscopy, Inc.2414%
Richard Wolf Gmbh1811%
Gyrus Acmi, Llc106%
Mahe Medical Gmbh64%
Aulea Medical Inc.64%
Hermann Medizintechnik Gmbh42%
Henke-Sass, Wolf Gmbh21%
Stryker Corporation11%
Avalign Technologies, Inc.11%
Avid Medical, Inc.11%

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

Brand names on the register (sample)

NAResectoscopy working unit,active, closed handle,Uretero-Renoscope,425mm,rigid,distal end 6/7.5ChUretero-Renoscope,430mm,rigid,distal end 7.5/10CHermann Medizintechnik GmbHSHARKS-LINEPRINCESSE-LINEmahe medical GmbHRZ Medizintechnik GmbHN/AVeloxionStrauss SurgicalAEDAED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscop

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

FDA product codes

CodeNameDevices
FDCRESECTOSCOPE, WORKING ELEMENT57
FAJCystoscope and accessories, flexible/rigid46
FAJCystoscope And Accessories, Flexible/Rigid27
FJLRESECTOSCOPE24
FDSGastroscope and accessories, flexible/rigid18
HIHHysteroscope (And Accessories)10

GMDN & GCC registration

  • GMDN code 35301 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 72% · 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) · 8Length (Millimeter) · 2

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

No closely related category with 50+ devices.

How many resectoscope products are registered in the US?

171 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resectoscope", from 12 companies. The largest labeler is Rz-Medizintechnik Gmbh with 29% of records.

Which FDA product codes apply?

FDC (RESECTOSCOPE, WORKING ELEMENT), FAJ (Cystoscope and accessories, flexible/rigid), FAJ (Cystoscope And Accessories, Flexible/Rigid), FJL (RESECTOSCOPE)

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.

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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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