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FDA 510(k)

Temno Elite Biopsy System

K-Number: K201166 · 2020-08-28

ApplicantMerit Medical Systems, Inc.
Decision Date2020-08-28
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Temno Elite Biopsy System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-08-28 under approval number K201166. 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 Temno Elite Biopsy System?

Temno Elite Biopsy System is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K201166.

When was Temno Elite Biopsy System approved by the FDA?

Temno Elite Biopsy System received FDA 510(k) clearance on 2020-08-28, under approval number K201166.

What company makes Temno Elite Biopsy System?

Temno Elite Biopsy System is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Temno Elite Biopsy System?

The FDA product code for Temno Elite Biopsy System is KNW.

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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.

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