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FDA 510(k)

LIVER BIOPSY KIT

K-Number: K943650 · 1994-08-26

ApplicantManan Medical Products, Inc.
Decision Date1994-08-26
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIVER BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Manan Medical Products, Inc.. It received FDA 510(k) clearance on 1994-08-26 under 510(k) number K943650. 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 LIVER BIOPSY KIT?

LIVER BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1994-08-26. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K943650.

When did LIVER BIOPSY KIT receive FDA 510(k) clearance?

LIVER BIOPSY KIT received FDA 510(k) clearance on 1994-08-26, under 510(k) number K943650.

Who is the listed applicant for LIVER BIOPSY KIT?

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

What is the FDA product code for LIVER BIOPSY KIT?

The FDA product code for LIVER BIOPSY KIT is KNW.

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Other records listing Manan Medical Products, 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.

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLEK011209MANAN SPRITACRE SPINAL NEEDLESK983620MANAN SPINAL NEEDLESK980536EPIDURAL NEEDLEK981386MANAN BLUNT NEEDLEK980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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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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