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FDA 510(k)

SELECTACUT BIOPSY DEVICE

K-Number: K914215 · 1992-02-24

ApplicantBiomni Medical Systems, Inc.
Decision Date1992-02-24
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SELECTACUT BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biomni Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-02-24 under 510(k) number K914215. 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 SELECTACUT BIOPSY DEVICE?

SELECTACUT BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1992-02-24. The listed applicant is Biomni Medical Systems, Inc.. The 510(k) number is K914215.

When did SELECTACUT BIOPSY DEVICE receive FDA 510(k) clearance?

SELECTACUT BIOPSY DEVICE received FDA 510(k) clearance on 1992-02-24, under 510(k) number K914215.

Who is the listed applicant for SELECTACUT BIOPSY DEVICE?

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

What is the FDA product code for SELECTACUT BIOPSY DEVICE?

The FDA product code for SELECTACUT BIOPSY DEVICE is KNW.

Related Clinical Trials

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.

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Other records listing Biomni Medical Systems, 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.

K961782BIO-BINKI

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

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