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FDA 510(k)

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL

K-Number: K081057 · 2008-06-17

ApplicantIntact Medical Corporation
Decision Date2008-06-17
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL is the device name listed in this FDA 510(k) record. The listed applicant is Intact Medical Corporation. It received FDA 510(k) clearance on 2008-06-17 under 510(k) number K081057. 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 INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL?

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL is a medical device that received FDA 510(k) clearance on 2008-06-17. The listed applicant is Intact Medical Corporation. The 510(k) number is K081057.

When did INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL receive FDA 510(k) clearance?

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL received FDA 510(k) clearance on 2008-06-17, under 510(k) number K081057.

Who is the listed applicant for INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL?

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

What is the FDA product code for INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL?

The FDA product code for INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL is KNW.

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Other records listing Intact Medical Corporation 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.

K152596Intact® Gen2 SystemK060413INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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