Cleared Special

K210654 - EnCor Breast Biopsy Probe with Rinse Tube

K210654 is the FDA 510(k) clearance for EnCor Breast Biopsy Probe with Rinse Tube by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code KNW) cleared through the Special 510(k) pathway after a 27-day FDA review.

K210654 · Senorx, Inc. · General & Plastic Surgery device
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Mar 2021
Decision
27d
Days
Class 2
Risk

K210654 is an FDA 510(k) clearance for the EnCor Breast Biopsy Probe with Rinse Tube. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on March 31, 2021 after a review of 27 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 K210654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2021
Decision Date March 31, 2021
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K210654.
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
K210946 · Promisemed Hangzhou Meditech Co., Ltd. · Aug 2021
EleVation Breast Biopsy System
K211933 · Bard Peripheral Vascular · Jul 2021
Avitus(r) Bone Harvester
K210631 · Avitus Orthopaedics, Inc. · Mar 2021
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