WellCare Anoscope

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230439

by Well Care (Wuhan) Medical Technology Co., Ltd.

Identifiers

510(k) Number: K230439 FDA 510(k)
FDA Product Code: FER FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The WellCare Anoscope is a medical device designed for use in gastroenterology and urology procedures. It is classified as a Class II device under FDA regulations and has received 510(k) clearance for marketing in the United States.

The device is intended for single-use applications and is supplied sterile. It is not MRI compatible and should be stored in a dry environment to maintain its integrity. The WellCare Anoscope is manufactured by Well Care (Wuhan) Medical Technology Co., Ltd. in China.

Frequently asked questions

What is the WellCare Anoscope used for?

The WellCare Anoscope is a medical device designed for use in gastroenterology and urology procedures.

Is the WellCare Anoscope sterile?

Yes, the device is supplied sterile and is intended for single-use applications.

How should the WellCare Anoscope be stored?

The device should be stored in a dry environment to maintain its integrity.

Is the WellCare Anoscope MRI compatible?

No, the WellCare Anoscope is not MRI compatible.

What is the regulatory status of the WellCare Anoscope?

The WellCare Anoscope has received 510(k) clearance for marketing in the United States.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Affordable Medicare Advantage Plans 2026 | Wellcare, Already a Member | Wellcare, Find Your Plan | Wellcare, Wellcare Pharmacy | Prescriptions, Travel Vaccinations, Pharmacy …, WellCare - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K230439	Class II	Active

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Manufacturer

Manufacturer: Well Care (Wuhan) Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K230439 24 fields · synced Oct 6, 2026