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FDA 510(k)

NOETIX, BIOPSY NEEDLE

K-Number: K893992 · 1989-09-08

ApplicantNoetix, Inc.
Decision Date1989-09-08
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NOETIX, BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Noetix, Inc.. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K893992. 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 NOETIX, BIOPSY NEEDLE?

NOETIX, BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Noetix, Inc.. The 510(k) number is K893992.

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

NOETIX, BIOPSY NEEDLE received FDA 510(k) clearance on 1989-09-08, under 510(k) number K893992.

Who is the listed applicant for NOETIX, BIOPSY NEEDLE?

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

What is the FDA product code for NOETIX, BIOPSY NEEDLE?

The FDA product code for NOETIX, BIOPSY NEEDLE is KNW.

Related Clinical Trials

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Other records listing Noetix, 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.

K881635NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEMK871365CAPSULECTOMER CYSTOTOME

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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