Wesee

Primary DI
06976712910477
Brand
Wesee
Company
Zhuhai Wesee Meditech Co., Ltd.
Model
SP11A
Device description
The Disposable Video Rhinolaryngoscope SP11A is sterile,single-use, flexible endoscope intened for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253184000Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.2026-03-25EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976712915530PackageGS150In Commercial Distribution
26976712918965PackageGS12In Commercial Distribution
06976712910477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697671291553016976712915530
2697671291896526976712918965
06976712910477069767129104776976712910477

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video otorhinolaryngoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.2Millimeter

Regulatory Flags#

DUNS number
621839804
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976712916400WeseeM110B2026-04-13
06976712917414WeseeCP11A2026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16