Cleared Special

K161805 - EnCor MRI Introducer Set, EnCor Probe Introducer

K161805 is an FDA 510(k) clearance for EnCor MRI Introducer Set, manufactured by Senorx, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 18-day FDA review.

K161805 · Senorx, Inc. · Gastroenterology & Urology device
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Jul 2016
Decision
18d
Days
Class 2
Risk

K161805 is an FDA 510(k) clearance for the EnCor MRI Introducer Set, EnCor Probe Introducer. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on July 19, 2016 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Senorx, Inc. devices

FDA 510(k) Submission Details - K161805

510(k) Number K161805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date July 19, 2016
Days to Decision 18 days
Submission Type Special
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
113d faster than avg
Panel avg: 131d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 293
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K161805.
Mammotome 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 Stylet
K153709 · Devicor Medical Products, Inc. · Aug 2016
CASSI II Rotational Core Biopsy System
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M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
K161409 · Mermaid Medical A/S · Aug 2016
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