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FDA 510(k)

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

K-Number: K190797 · 2019-11-18

ApplicantReed Medical (Zhejiang) Co., Ltd.
Decision Date2019-11-18
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) is a medical device manufactured by Reed Medical (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-11-18 under approval number K190797. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)?

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) is a medical device that received FDA 510(k) clearance on 2019-11-18. It is manufactured by Reed Medical (Zhejiang) Co., Ltd.. The 510(k) number is K190797.

When was Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) approved by the FDA?

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) received FDA 510(k) clearance on 2019-11-18, under approval number K190797.

What company makes Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)?

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) is manufactured by Reed Medical (Zhejiang) Co., Ltd..

What is the FDA product code for Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)?

The FDA product code for Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) is HIH.

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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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