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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2018-08-23 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K181974.

When did MyoSure XL Tissue Removal Device for Fluent receive FDA 510(k) clearance?

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

Who is the listed applicant for MyoSure XL Tissue Removal Device for Fluent?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: HIH)

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.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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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