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FDA 510(k)

REVOLUTION FULL CORE BIOPSY

K-Number: K090611 · 2009-06-04

ApplicantInrad
Decision Date2009-06-04
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REVOLUTION FULL CORE BIOPSY is the device name listed in this FDA 510(k) record. The listed applicant is Inrad. It received FDA 510(k) clearance on 2009-06-04 under 510(k) number K090611. 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 REVOLUTION FULL CORE BIOPSY?

REVOLUTION FULL CORE BIOPSY is a medical device that received FDA 510(k) clearance on 2009-06-04. The listed applicant is Inrad. The 510(k) number is K090611.

When did REVOLUTION FULL CORE BIOPSY receive FDA 510(k) clearance?

REVOLUTION FULL CORE BIOPSY received FDA 510(k) clearance on 2009-06-04, under 510(k) number K090611.

Who is the listed applicant for REVOLUTION FULL CORE BIOPSY?

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

What is the FDA product code for REVOLUTION FULL CORE BIOPSY?

The FDA product code for REVOLUTION FULL CORE BIOPSY is KNW.

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Other records listing Inrad as applicant

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.

K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018K063238ULTRACLIP II WING AND ULTRACLIP II COILK042341ULTRACLIP II USK041201ULTRACLIP II MRK000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

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Related Devices (Code: KNW)

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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed 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.

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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