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)

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles

K-Number: K160316 · 2016-10-27

ApplicantM.D.L. S.R.L.
Decision Date2016-10-27
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles is a medical device manufactured by M.D.L. S.R.L.. It received FDA 510(k) clearance on 2016-10-27 under approval number K160316. 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 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles?

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by M.D.L. S.R.L.. The 510(k) number is K160316.

When was SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles approved by the FDA?

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles received FDA 510(k) clearance on 2016-10-27, under approval number K160316.

What company makes SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles?

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles is manufactured by M.D.L. S.R.L..

What is the FDA product code for SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles?

The FDA product code for SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles is KNW.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING 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 NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine 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: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026) PMID: 40498444 Assessing the Impact of End-of-Life Processing on Reusable Medical Devices. Biomedical instrumentation & technology (2025) PMID: 40487675 Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea. Obesity pillars (2025)

Related Devices (Code: KNW)

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. K152989Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor 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.

↑