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FDA 510(k)

HTx Disposable Hysteroscope System

K-Number: K231260 · 2024-03-05

ApplicantSuzhou AcuVu Medical Technology Co., Ltd.
Decision Date2024-03-05
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HTx Disposable Hysteroscope System is a medical device manufactured by Suzhou AcuVu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-05 under approval number K231260. 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 HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is a medical device that received FDA 510(k) clearance on 2024-03-05. It is manufactured by Suzhou AcuVu Medical Technology Co., Ltd.. The 510(k) number is K231260.

When was HTx Disposable Hysteroscope System approved by the FDA?

HTx Disposable Hysteroscope System received FDA 510(k) clearance on 2024-03-05, under approval number K231260.

What company makes HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is manufactured by Suzhou AcuVu Medical Technology Co., Ltd..

What is the FDA product code for HTx Disposable Hysteroscope System?

The FDA product code for HTx Disposable Hysteroscope System is HIH.

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Other Devices by Suzhou AcuVu Medical Technology Co., Ltd.

K254050Manual Tissue Removal Device

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.

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