Decision Date2019-05-10
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Hysteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K181545. 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 Hysteroscope System?
Hysteroscope System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K181545.
When did Hysteroscope System receive FDA 510(k) clearance?
Hysteroscope System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K181545.
Who is the listed applicant for Hysteroscope System?
The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hysteroscope System?
The FDA product code for Hysteroscope System is HIH.
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Other records listing Shanghai AnQing Medical Instrument Co., Ltd. as applicant
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.
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Related Devices (Code: 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.