Device Explorer · FDA GUDID · GMDN 12245

Ear knife

A hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small a

US‑registered devices863in commercial distribution
Companies34labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Fentex Medical Gmbh728%
Integra Lifesciences Production Corporation668%
Medicon Eg. Chirurgiemechaniker-Genossenschaft607%
Karl Storz Gmbh & Co. Kg556%
Boss Instruments, Ltd., Inc.526%
Integra Microfrance496%
Bausch & Lomb Incorporated445%
Spiggle & Theis Medizintechnik Gmbh425%

Top labelers

CompanyDevicesShare
Fentex Medical Gmbh728%
Integra Lifesciences Production Corporation668%
Medicon Eg. Chirurgiemechaniker-Genossenschaft607%
Karl Storz Gmbh & Co. Kg556%
Boss Instruments, Ltd., Inc.526%
Integra Microfrance496%
Bausch & Lomb Incorporated445%
Spiggle & Theis Medizintechnik Gmbh425%
Surgix Medical Llc384%
Steris Corporation324%
Hnm Stainless, Llc.314%
Jedmed Instrument Company303%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexRosen round knifeTeschner sickle knifeSchuknecht roller knifeMcCabe flap knifeHough flap knifeDornhofer sickle knifeRosen raspatoryIncudostapedial joint knifeFENTEXFisch sickle knifeRosen lacet knifeLucae tympanum perforatorPolitzer tympanum perforatorPlester flap knifeWullstein sickle knife

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

FDA product codes

CodeNameDevices
JYOKNIFE, EAR192
LRCINSTRUMENT, ENT MANUAL SURGICAL190
JYOKnife, Ear183
KTGKNIFE, ENT153
EMFKNIFE, SURGICAL49
KTGKnife, Ent47

GMDN & GCC registration

  • GMDN code 12245 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 82% · 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

Length (Inch) · 34Angle (degree) · 16Width (Millimeter) · 15Length (Millimeter) · 14Outer Diameter (Millimeter) · 9Length (Centimeter) · 3

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

How many ear knife products are registered in the US?

863 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ear knife", from 34 companies. The largest labeler is Fentex Medical Gmbh with 8% of records.

Which FDA product codes apply?

JYO (KNIFE, EAR), LRC (INSTRUMENT, ENT MANUAL SURGICAL), JYO (Knife, Ear), KTG (KNIFE, ENT)

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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