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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 the device name listed in this FDA 510(k) record. The listed applicant is Well Care (Wuhan) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) 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. The listed applicant is Well Care (Wuhan) Medical Technology Co., Ltd.. The 510(k) number is K230439.

When did WellCare Anoscope receive FDA 510(k) clearance?

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

Who is the listed applicant for WellCare Anoscope?

The FDA 510(k) record lists Well Care (Wuhan) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WellCare Anoscope?

The FDA product code for WellCare Anoscope is FER.

Related Devices (Code: FER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K242668Gastro Concepts Air AssistGastro Concepts, LLCK200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.

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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