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FDA 510(k)

Hysteroscopy System

K-Number: K172151 · 2018-04-09

Decision Date2018-04-09
Product CodeHGH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hysteroscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Chongquin Jinshan Science & Technology (Group) Co., Ltd.. It received FDA 510(k) clearance on 2018-04-09 under 510(k) number K172151. The device is classified under product code HGH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hysteroscopy System?

Hysteroscopy System is a medical device that received FDA 510(k) clearance on 2018-04-09. The listed applicant is Chongquin Jinshan Science & Technology (Group) Co., Ltd.. The 510(k) number is K172151.

When did Hysteroscopy System receive FDA 510(k) clearance?

Hysteroscopy System received FDA 510(k) clearance on 2018-04-09, under 510(k) number K172151.

Who is the listed applicant for Hysteroscopy System?

The FDA 510(k) record lists Chongquin Jinshan Science & Technology (Group) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hysteroscopy System?

The FDA product code for Hysteroscopy System is HGH.

Related Devices (Code: HGH)

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.

Official Source

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