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FDA 510(k)

ENCIRCLE LOCALIZATION DEVICE

K-Number: K022286 · 2002-10-11

ApplicantVivant Medical, Inc.
Decision Date2002-10-11
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENCIRCLE LOCALIZATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vivant Medical, Inc.. It received FDA 510(k) clearance on 2002-10-11 under 510(k) number K022286. 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 ENCIRCLE LOCALIZATION DEVICE?

ENCIRCLE LOCALIZATION DEVICE is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Vivant Medical, Inc.. The 510(k) number is K022286.

When did ENCIRCLE LOCALIZATION DEVICE receive FDA 510(k) clearance?

ENCIRCLE LOCALIZATION DEVICE received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022286.

Who is the listed applicant for ENCIRCLE LOCALIZATION DEVICE?

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

What is the FDA product code for ENCIRCLE LOCALIZATION DEVICE?

The FDA product code for ENCIRCLE LOCALIZATION DEVICE is KNW.

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Other records listing Vivant Medical, Inc. 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.

K050223VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCERK040279VIVARING MICROWAVE ABLATION PROBEK032702VIVATIP MICROWAVE ABLATION PROBEK032047TRI-LOOP MICROWAVE ABLATION PROBEK031556VIVATHERM THEMPERATURE MEASUREMENT SYSTEMK023311LOOP MICROWAVE ABLATION PROBE

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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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