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FDA 510(k)

MEADOX SURGIMED BIOPSY GUN AND NEEDLE

K-Number: K902461 · 1990-07-16

ApplicantMeadox Surgimed, Inc.
Decision Date1990-07-16
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEADOX SURGIMED BIOPSY GUN AND NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K902461. 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 MEADOX SURGIMED BIOPSY GUN AND NEEDLE?

MEADOX SURGIMED BIOPSY GUN AND NEEDLE is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K902461.

When did MEADOX SURGIMED BIOPSY GUN AND NEEDLE receive FDA 510(k) clearance?

MEADOX SURGIMED BIOPSY GUN AND NEEDLE received FDA 510(k) clearance on 1990-07-16, under 510(k) number K902461.

Who is the listed applicant for MEADOX SURGIMED BIOPSY GUN AND NEEDLE?

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

What is the FDA product code for MEADOX SURGIMED BIOPSY GUN AND NEEDLE?

The FDA product code for MEADOX SURGIMED BIOPSY GUN AND NEEDLE is KNW.

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Other records listing Meadox Surgimed, Inc. as applicant

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K944143MS CLASSIQUE BALLOON CATHETERK945061NOPROFILE OLBERT CATHETER SYSTEMK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK905181NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

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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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