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Device Explorer · FDA GUDID · GMDN 35009

Over-guidewire oesophageal dilator

A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes

US‑registered devices57in commercial distribution
Companies3labelers on GUDID
Single‑use33%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Diversatek Healthcare, Inc.3867%
Cook Incorporated1832%
Spiggle & Theis Medizintechnik Gmbh12%

Top labelers

CompanyDevicesShare
Diversatek Healthcare, Inc.3867%
Cook Incorporated1832%
Spiggle & Theis Medizintechnik Gmbh12%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Laser-Vocal cord spreaderSavarySavary-GilliardCOOKSafeGuide® SingleSafeGuide®

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

FDA product codes

CodeNameDevices
KNQDilator, Esophageal38
KNQDilator, esophageal23
LRCINSTRUMENT, ENT MANUAL SURGICAL1

GMDN & GCC registration

  • GMDN code 35009 · non‑implantable
  • Single‑use 33% · sterile 0% · 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

Catheter Gauge (French) · 16Length (Centimeter) · 4

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

No closely related category with 50+ devices.

How many over-guidewire oesophageal dilator products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Over-guidewire oesophageal dilator", from 3 companies. The largest labeler is Diversatek Healthcare, Inc. with 67% of records.

Which FDA product codes apply?

KNQ (Dilator, Esophageal), KNQ (Dilator, esophageal), LRC (INSTRUMENT, ENT MANUAL SURGICAL)

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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