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FDA 510(k)

MODIFIED BIOPSY NEEDLE

K-Number: K951229 · 1995-04-06

ApplicantBiopsys Medical, Inc.
Decision Date1995-04-06
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Biopsys Medical, Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K951229. 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 MODIFIED BIOPSY NEEDLE?

MODIFIED BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Biopsys Medical, Inc.. The 510(k) number is K951229.

When did MODIFIED BIOPSY NEEDLE receive FDA 510(k) clearance?

MODIFIED BIOPSY NEEDLE received FDA 510(k) clearance on 1995-04-06, under 510(k) number K951229.

Who is the listed applicant for MODIFIED BIOPSY NEEDLE?

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

What is the FDA product code for MODIFIED BIOPSY NEEDLE?

The FDA product code for MODIFIED BIOPSY NEEDLE is KNW.

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Other records listing Biopsys Medical, 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.

K970817MICROMARK CLIPK970565MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)K963015SURGICAL STAPLE MARKER DEVICE (MODIFY)K960019RETRACTOR ARM CLAMPK953880BIOPSY NEEDLEK953962FORCEPS

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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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