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FDA 510(k)

CHIBA SONO

K-Number: K113209 · 2011-11-21

ApplicantPajunk GmbH
Decision Date2011-11-21
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHIBA SONO is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2011-11-21 under 510(k) number K113209. 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 CHIBA SONO?

CHIBA SONO is a medical device that received FDA 510(k) clearance on 2011-11-21. The listed applicant is Pajunk GmbH. The 510(k) number is K113209.

When did CHIBA SONO receive FDA 510(k) clearance?

CHIBA SONO received FDA 510(k) clearance on 2011-11-21, under 510(k) number K113209.

Who is the listed applicant for CHIBA SONO?

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

What is the FDA product code for CHIBA SONO?

The FDA product code for CHIBA SONO is KNW.

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Other records listing Pajunk GmbH 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.

K113207SONO TAP, TUOHY SONOK060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVK053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETK053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPK043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSK042979MODIFICATION TO: PLEXALONG SETS

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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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