Cleared Traditional

K152872 - K2M Fenestrated Tap System

K152872 is an FDA 510(k) clearance for K2M Fenestrated Tap System, manufactured by K2m. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K152872 · K2m · Gastroenterology & Urology device
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Jan 2016
Decision
97d
Days
Class 2
Risk

K152872 is an FDA 510(k) clearance for the K2M Fenestrated Tap System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on January 5, 2016 after a review of 97 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 K2m devices

FDA 510(k) Submission Details - K152872

510(k) Number K152872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date January 05, 2016
Days to Decision 97 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
34d faster than avg
Panel avg: 131d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K152872.
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · Devicor Medical Products, Inc. · Feb 2016
Intact® Gen2 System
K152596 · Intact Medical Corporation · Feb 2016
New Medax Biopsy Systems
K142125 · Medax Srl Unipersonale · Dec 2015
Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015
Avitus Bone Harvester
K152474 · Avitus Orthopaedics, Inc. · Oct 2015