Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Remington Medical, Inc.. It received FDA 510(k) clearance on 2019-07-12 under approval 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. It is manufactured by Remington Medical, Inc.. The 510(k) number is K191315.

When was Remington Medical, Inc. Automatic Cutting Needle (NAC) approved by the FDA?

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

What company makes Remington Medical, Inc. Automatic Cutting Needle (NAC)?

Remington Medical, Inc. Automatic Cutting Needle (NAC) is manufactured by Remington Medical, Inc..

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.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06741657 A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways COMPLETED NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING NCT02119611 Deep Brain Stimulation Therapy in Movement Disorders RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Remington Medical, Inc.

K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger 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) 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)

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, 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.

↑