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FDA 510(k)

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

K-Number: K172566 · 2017-09-20

ApplicantHologic, Inc.
Decision Date2017-09-20
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K172566. 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 Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices?

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Hologic, Inc.. The 510(k) number is K172566.

When did Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices receive FDA 510(k) clearance?

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices received FDA 510(k) clearance on 2017-09-20, under 510(k) number K172566.

Who is the listed applicant for Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices?

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 Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices?

The FDA product code for Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices 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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