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FDA 510(k)

WellCare Anoscope

K-Number: K230439 · 2023-12-22

ApplicantWell Care (Wuhan) Medical Technology Co., Ltd.
Decision Date2023-12-22
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WellCare Anoscope is a medical device manufactured by Well Care (Wuhan) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval number K230439. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WellCare Anoscope?

WellCare Anoscope is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Well Care (Wuhan) Medical Technology Co., Ltd.. The 510(k) number is K230439.

When was WellCare Anoscope approved by the FDA?

WellCare Anoscope received FDA 510(k) clearance on 2023-12-22, under approval number K230439.

What company makes WellCare Anoscope?

WellCare Anoscope is manufactured by Well Care (Wuhan) Medical Technology Co., Ltd..

What is the FDA product code for WellCare Anoscope?

The FDA product code for WellCare Anoscope is FER.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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