Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hysteroscope System

K-Number: K181545 · 2019-05-10

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2019-05-10
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hysteroscope System is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-05-10 under approval 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. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K181545.

When was Hysteroscope System approved by the FDA?

Hysteroscope System received FDA 510(k) clearance on 2019-05-10, under approval number K181545.

What company makes Hysteroscope System?

Hysteroscope System is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..

What is the FDA product code for Hysteroscope System?

The FDA product code for Hysteroscope System is HIH.

Other Devices by Shanghai AnQing Medical Instrument Co., Ltd.

K180367Ureterorenoscope System K201293Ureterorenoscope System K211169Bronchoscope System K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

View all 14 devices →

Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

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.

↑