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FDA 510(k)

NEEDLE OR CUTTER

K-Number: K953399 · 1995-10-30

ApplicantBiophysic Medical, Inc.
Decision Date1995-10-30
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE OR CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Biophysic Medical, Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K953399. 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 NEEDLE OR CUTTER?

NEEDLE OR CUTTER is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K953399.

When did NEEDLE OR CUTTER receive FDA 510(k) clearance?

NEEDLE OR CUTTER received FDA 510(k) clearance on 1995-10-30, under 510(k) number K953399.

Who is the listed applicant for NEEDLE OR CUTTER?

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

What is the FDA product code for NEEDLE OR CUTTER?

The FDA product code for NEEDLE OR CUTTER is KNW.

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Other records listing Biophysic Medical, Inc. as applicant

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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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