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FDA 510(k)

MyoSure XL Tissue Removal Device for Fluent

K-Number: K181974 · 2018-08-23

ApplicantHologic, Inc.
Decision Date2018-08-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MyoSure XL Tissue Removal Device for Fluent is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2018-08-23 under approval number K181974. 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 XL Tissue Removal Device for Fluent?

MyoSure XL Tissue Removal Device for Fluent is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Hologic, Inc.. The 510(k) number is K181974.

When was MyoSure XL Tissue Removal Device for Fluent approved by the FDA?

MyoSure XL Tissue Removal Device for Fluent received FDA 510(k) clearance on 2018-08-23, under approval number K181974.

What company makes MyoSure XL Tissue Removal Device for Fluent?

MyoSure XL Tissue Removal Device for Fluent is manufactured by Hologic, Inc..

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

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

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

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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