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FDA 510(k)

Remington Medical, Inc. Automatic Cutting Needle (NAC)

K-Number: K191315 · 2019-07-12

ApplicantRemington Medical, Inc.
Decision Date2019-07-12
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Remington Medical, Inc. Automatic Cutting Needle (NAC) is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191315. 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 Remington Medical, Inc. Automatic Cutting Needle (NAC)?

Remington Medical, Inc. Automatic Cutting Needle (NAC) is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Remington Medical, Inc.. The 510(k) number is K191315.

When did Remington Medical, Inc. Automatic Cutting Needle (NAC) receive FDA 510(k) clearance?

Remington Medical, Inc. Automatic Cutting Needle (NAC) received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191315.

Who is the listed applicant for Remington Medical, Inc. Automatic Cutting Needle (NAC)?

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

What is the FDA product code for Remington Medical, Inc. Automatic Cutting Needle (NAC)?

The FDA product code for Remington Medical, Inc. Automatic Cutting Needle (NAC) is KNW.

Other records listing Remington 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.

K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerK212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

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.

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.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, 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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