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FDA 510(k)

QUICK CORE II

K-Number: K941256 · 1994-07-13

ApplicantProact, Ltd.
Decision Date1994-07-13
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

QUICK CORE II is the device name listed in this FDA 510(k) record. The listed applicant is Proact, Ltd.. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K941256. 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 QUICK CORE II?

QUICK CORE II is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Proact, Ltd.. The 510(k) number is K941256.

When did QUICK CORE II receive FDA 510(k) clearance?

QUICK CORE II received FDA 510(k) clearance on 1994-07-13, under 510(k) number K941256.

Who is the listed applicant for QUICK CORE II?

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

What is the FDA product code for QUICK CORE II?

The FDA product code for QUICK CORE II is KNW.

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Other records listing Proact, Ltd. 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.

K926559PROACT BIOPSY NEEDLE ENCHANCEMENTSK913306BONE-TEMNO/STERNUM-TEMNOK902320BAUER FLEXI-TEMNO BIOPSY NEEDLEK902319BAUER TEMNO BIOPSY NEEDLE

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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