Device Explorer · FDA GUDID · GMDN 35692

Rigid endoscope obturator

An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into

US‑registered devices632in commercial distribution
Companies26labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg19331%
Sopro-Comeg Gmbh13722%
Richard Wolf Gmbh6911%
Stryker Corporation6310%
American Medical Endoscopy, Inc.488%
Olympus Winter & Ibe Gmbh234%
Intuitive Surgical, Inc.152%
Gyrus Acmi, Llc122%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg19331%
Sopro-Comeg Gmbh13722%
Richard Wolf Gmbh6911%
Stryker Corporation6310%
American Medical Endoscopy, Inc.488%
Olympus Winter & Ibe Gmbh234%
Intuitive Surgical, Inc.152%
Gyrus Acmi, Llc122%
Henke-Sass, Wolf Gmbh102%
Arthrex, Inc.81%
Teleflex Incorporated61%
Conmed Corporation61%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DRI-LOKNAEDINTRAKENDOTRACSpeed-LockDri-LokUrethrotome-obturator only, 21Ch.Standard obturator quick-lock f. resectoscope shLitho standard obturator for 35.009.10QLRectosigmoidoscope with ObturatorN/ABLUEENDOUROLIFT ®Shaft obturatorintENTS®Obturator

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

FDA product codes

CodeNameDevices
NBHAccessories, arthroscopic106
FAJCystoscope and accessories, flexible/rigid79
ODBendoscopic contamination prevention sheath66
FAJCystoscope And Accessories, Flexible/Rigid43
GCJLaparoscope, general & plastic surgery41
FDCRESECTOSCOPE, WORKING ELEMENT39

GMDN & GCC registration

  • GMDN code 35692 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 59% · 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

Outer Diameter (Millimeter) · 129Length (Millimeter) · 30Width (Millimeter) · 2Length (Centimeter) · 1

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How many rigid endoscope obturator products are registered in the US?

632 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid endoscope obturator", from 26 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 31% of records.

Which FDA product codes apply?

NBH (Accessories, arthroscopic), FAJ (Cystoscope and accessories, flexible/rigid), ODB (endoscopic contamination prevention sheath), 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.

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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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