FDA 510(k)

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set

K-Number: K170008 · 2017-02-28

Decision Date2017-02-28

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-02-28 under 510(k) number K170008. 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 Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set?

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Cook Incorporated. The 510(k) number is K170008.

When did Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set receive FDA 510(k) clearance?

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set received FDA 510(k) clearance on 2017-02-28, under 510(k) number K170008.

Who is the listed applicant for Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set?

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

What is the FDA product code for Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set?

The FDA product code for Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set is KNW.

Related Clinical Trials

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.

NCT05258357Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure StudyCOMPLETED

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Related Devices (Code: KNW)

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.