Consulting Wallah › Device Explorer › Catheters & tubes › Nasal/paranasal balloon catheter, non-tracking
Device Explorer · FDA GUDID · GMDN 48140

Nasal/paranasal balloon catheter, non-tracking

A flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to

US‑registered devices65in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medtronic Xomed, Inc.2538%
Acclarent, Inc.1726%
Stryker Corporation812%
Fiagon Na Llc69%
Fiagon Gmbh46%
Meril Life Sciences Private Limited35%
Excelent, Inc.23%

Top labelers

CompanyDevicesShare
Medtronic Xomed, Inc.2538%
Acclarent, Inc.1726%
Stryker Corporation812%
Fiagon Na Llc69%
Fiagon Gmbh46%
Meril Life Sciences Private Limited35%
Excelent, Inc.23%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VenSure 4D Balloon Dilation SystemVenSure Nav Balloon Dilation SystemVenSure Light Balloon Dilation SystemVenSure Balloon Dilation SystemSHAPEVenSure™ Balloon Dilation SystemBB 8 Sinus Dilation KitBB8 Sinus Dilation KitXprESS UltraXprESS LoProfileNuVent™NuVent ™RELIEVA TRACTRELIEVA SPINPLUS NAVMesireTM Sinus Balloon CatheterRELIEVA ULTIRRA NAV

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

FDA product codes

CodeNameDevices
LRCINSTRUMENT, ENT MANUAL SURGICAL43
LRCInstrument, Ent Manual Surgical28
PNZEustachian Tube Balloon Dilation Device20
QGKBalloon, nasal airway8
PGWEar, Nose, and Throat Stereotaxic Instrument4
QGKBalloon, Nasal Airway1

GMDN & GCC registration

  • GMDN code 48140 · 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

Outer Diameter (Millimeter) · 20Length (Millimeter) · 20Balloon Diameter (Millimeter) · 13Balloon Length (Millimeter) · 13Angle (degree) · 5Balloon Rated Burst Pressure (Atmosphere) · 1

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

No closely related category with 50+ devices.

How many nasal/paranasal balloon catheter, non-tracking products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nasal/paranasal balloon catheter, non-tracking", from 7 companies. The largest labeler is Medtronic Xomed, Inc. with 38% of records.

Which FDA product codes apply?

LRC (INSTRUMENT, ENT MANUAL SURGICAL), LRC (Instrument, Ent Manual Surgical), PNZ (Eustachian Tube Balloon Dilation Device), QGK (Balloon, nasal airway)

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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