Cleared Traditional

K201166 - Temno Elite Biopsy System

K201166 is the FDA 510(k) clearance for Temno Elite Biopsy System by Merit Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K201166 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
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Aug 2020
Decision
119d
Days
Class 2
Risk

K201166 is an FDA 510(k) clearance for the Temno Elite Biopsy System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 28, 2020 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K201166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date August 28, 2020
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 156
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K201166.
VMCore Biopsy Needle
K201650 · Uro-1, Inc. · Jan 2021
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
K203397 · Biopsybell S.R.L. · Jan 2021
Ran-Flex-B Bone Marrow Aspiration Needle
K202287 · Ranfac Corporation · Sep 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · Devicor Medical Products, Inc. · Aug 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K201244 · Transmed7, LLC · Aug 2020
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
K192099 · Medax Srl Unipersonale · Apr 2020