FDA 510(k)

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver

K-Number: K230015 · 2023-06-16

Decision Date2023-06-16

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver is a medical device manufactured by Laurane Medical Sas. It received FDA 510(k) clearance on 2023-06-16 under approval number K230015. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver?

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Laurane Medical Sas. The 510(k) number is K230015.

When was OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver approved by the FDA?

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver received FDA 510(k) clearance on 2023-06-16, under approval number K230015.

What company makes OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver?

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver is manufactured by Laurane Medical Sas.

What is the FDA product code for OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver?

The FDA product code for OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver is KNW.

Related Clinical Trials

NCT06090669 Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency RECRUITING NCT06904066 Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies RECRUITING NCT03568292 Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures SUSPENDED NCT07136324 Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry ACTIVE_NOT_RECRUITING NCT07162038 Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation RECRUITING NCT03173937 Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome RECRUITING

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, 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.