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FDA 510(k)

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE

K-Number: K892071 · 1989-08-08

ApplicantAmedic USA
Decision Date1989-08-08
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1989-08-08 under 510(k) number K892071. 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 GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE?

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE is a medical device that received FDA 510(k) clearance on 1989-08-08. The listed applicant is Amedic USA. The 510(k) number is K892071.

When did GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE receive FDA 510(k) clearance?

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE received FDA 510(k) clearance on 1989-08-08, under 510(k) number K892071.

Who is the listed applicant for GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE?

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

What is the FDA product code for GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE?

The FDA product code for GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE is KNW.

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Other records listing Amedic USA 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.

K897120EQUIP COVERS, STERILEK892070GENERAL IVT NEEDLE GUIDE KIT, STERILEK892069EXTENDED COVERS, STERILEK892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILEK871565ULTRASOUND TRANSDUCER GEL, STERILE

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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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