Device Explorer · FDA GUDID · GMDN 10025

Adenotome

A hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the

US‑registered devices111in commercial distribution
Companies13labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg2220%
Medicon Eg. Chirurgiemechaniker-Genossenschaft1614%
Integra Lifesciences Production Corporation1413%
Integra Microfrance1211%
Aspen Surgical Products, Inc.87%
Fentex Medical Gmbh76%
Novo Surgical, Inc.76%
Aesculap Ag65%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg2220%
Medicon Eg. Chirurgiemechaniker-Genossenschaft1614%
Integra Lifesciences Production Corporation1413%
Integra Microfrance1211%
Aspen Surgical Products, Inc.87%
Fentex Medical Gmbh76%
Novo Surgical, Inc.76%
Aesculap Ag65%
Avalign Technologies, Inc.65%
Teleflex Incorporated55%
Steris Corporation44%
Rz-Medizintechnik Gmbh33%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FENTEXRZ Medizintechnik GmbHn.a.MediconAESCULAPSymmetrySymmetry SurgicalSymmetry ShambaughSymmetry LaforceMilleniumMillenniumAvalignPILLINGV. MuellerIntegra® Jarit®MicroFrance®

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

FDA product codes

CodeNameDevices
KBHADENOTOME66
LRCINSTRUMENT, ENT MANUAL SURGICAL35
KBHAdenotome12
KBJCURETTE, ADENOID12
KAEFORCEPS, ENT4
KALRETRACTOR, ENT2

GMDN & GCC registration

  • GMDN code 10025 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 99% · 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

Width (Millimeter) · 8Length (Centimeter) · 5

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

No closely related category with 50+ devices.

How many adenotome products are registered in the US?

111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Adenotome", from 13 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 20% of records.

Which FDA product codes apply?

KBH (ADENOTOME), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KBH (Adenotome), KBJ (CURETTE, ADENOID)

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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