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FDA 510(k)

Single Use Endoscope Valves Set

K-Number: K192048 · 2020-05-14

ApplicantAnrei Medical (Hangzhou) Co., Ltd.
Decision Date2020-05-14
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Endoscope Valves Set is a medical device manufactured by Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under approval number K192048. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Endoscope Valves Set?

Single Use Endoscope Valves Set is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K192048.

When was Single Use Endoscope Valves Set approved by the FDA?

Single Use Endoscope Valves Set received FDA 510(k) clearance on 2020-05-14, under approval number K192048.

What company makes Single Use Endoscope Valves Set?

Single Use Endoscope Valves Set is manufactured by Anrei Medical (Hangzhou) Co., Ltd..

What is the FDA product code for Single Use Endoscope Valves Set?

The FDA product code for Single Use Endoscope Valves Set is ODC.

Related Clinical Trials

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Other Devices by Anrei Medical (Hangzhou) Co., Ltd.

K201771Single Use Rotatable and Repositionable Hemoclip K210917Single Use Injection Needle K202987Rescue Pulmonary Grasping Forceps K210660Stone Retrieval Balloon Catheter K212999Multi-Functional Electrosurgical Knife

Related Devices (Code: ODC)

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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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