Cleared Special

K233220 - EnCor Enspire™Breast Biopsy System (E4115, E4230) (FDA 510(k) Clearance)

Also includes:
EnCor™ Breast Biopsy Driver (DRENCOR) EnCor™ MRI Breast Biopsy Driver (DRENCORMR) EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV) EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233220 · Senorx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
29d
Days
Class 2
Risk

K233220 is an FDA 510(k) clearance for the EnCor Enspire™Breast Biopsy System (E4115, E4230). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on October 27, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery 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

Submission Details

510(k) Number K233220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date October 27, 2023
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 359
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K233220.
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · Bard Peripheral Vascular, Inc. · Dec 2025
Resitu Slider 09 (RESL09)
K252183 · Resitu Medical AB · Sep 2025
Forcyte Autograft Harvest Kit
K243407 · Forcyte Medical, LLC · Jul 2025
Disposable Biopsy Needle
K244018 · Zhejiang Curaway Medical Technology Co., Ltd. · Jul 2025