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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2017-09-20 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K172566.
When was Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices approved by the FDA?
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices received FDA 510(k) clearance on 2017-09-20, under approval number K172566.
What company makes Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices?
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices is manufactured by Hologic, Inc..
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.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT03053791
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
RECRUITING
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
NCT07608939
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
NOT_YET_RECRUITING
NCT02030691
Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress
COMPLETED
Related PubMed Literature
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
PMID: 42056377
Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.
Scientific reports (2026)
PMID: 41619565
Integration of materiovigilance in Unani medicine: A step towards patient safety.
Journal of Ayurveda and integrative medicine (2026)
PMID: 41516911
Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation.
Polymers (2025)
Other Devices by Hologic, Inc.
K153486Affirm Prone Biopsy System
K172629Panther Fusion AdV/hMPV/RV Assay
K172282Panther Fusion Paraflu Assay
K163623Quantra
K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
K162673Aptima Herpes Simplex Viruses 1 & 2 Assay
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
K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.
K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.
K180496TruClear Elite HysteroscopeCovidien
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.