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FDA 510(k)

MyoSure MANUAL Tissue Removal Device

K-Number: K173901 · 2018-05-08

ApplicantHologic, Inc.
Decision Date2018-05-08
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MyoSure MANUAL Tissue Removal Device is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2018-05-08 under approval number K173901. 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 MyoSure MANUAL Tissue Removal Device?

MyoSure MANUAL Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2018-05-08. It is manufactured by Hologic, Inc.. The 510(k) number is K173901.

When was MyoSure MANUAL Tissue Removal Device approved by the FDA?

MyoSure MANUAL Tissue Removal Device received FDA 510(k) clearance on 2018-05-08, under approval number K173901.

What company makes MyoSure MANUAL Tissue Removal Device?

MyoSure MANUAL Tissue Removal Device is manufactured by Hologic, Inc..

What is the FDA product code for MyoSure MANUAL Tissue Removal Device?

The FDA product code for MyoSure MANUAL Tissue Removal Device is HIH.

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Related PubMed Literature

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Other Devices by Hologic, Inc.

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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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