Wesee

Basic Information

• Brand Name: Wesee
• Primary DI: 06976712910477
• Version / Model: SP11A
• Company Name: Zhuhai Wesee Meditech Co., Ltd.
• Labeler DUNS: 621839804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-13
• Public Version: 1
• Public Version Date: 2026-04-21
• Public Version Status: New
• Public Device Record Key: 7811c515-6046-46b2-be35-3c81871beea8

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63330	Flexible video otorhinolaryngoscope, single-use	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06976712910477	GS1
Package	16976712915530	GS1	box	50	In Commercial Distribution
Package	26976712918965	GS1	carton	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K253184	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.2	Millimeter