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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 the device name listed in this FDA 510(k) record. The listed applicant is Reed Medical (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) 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. The listed applicant is Reed Medical (Zhejiang) Co., Ltd.. The 510(k) number is K190797.

When did Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)?

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

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.

Related Devices (Code: HIH)

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Official Source

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

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