510(k) Report

510(k) · Cleared

Cleared

Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable

K012023510(k) TraditionalCleared Sep 12, 200176-day reviewClass II21 CFR 876.1075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Senorx, Inc. · KNW Instrument, Biopsy

Cleared on Sep 12, 2001 as substantially equivalent to K900903 (Milex Products, Inc., 1990) and 2 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1979. 31 later devices descend from it.

Decided
Sep 12, 2001
Review
76 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K790187 (1979). 3 ancestors in all. 31 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1990: 1 other ancestor2002: 2 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2019: 2 descendants cleared2015: 3 descendants cleared2024: 2 descendants cleared2016: 4 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared2017: 5 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 2 descendants clearedK790187 · Bovie Hand Control · Sybron Corp. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants10 generations forward: 2 descendants11 generations forward: 3 descendants12 generations forward: 3 descendants13 generations forward: 2 descendants14 generations forward: 1 descendant K790187 · Bovie Hand Control · Sybron Corp. · 19790+5+10
  1. Root · 1 generation backK790187 Bovie Hand ControlSybron Corp. · 1979
  2. This deviceK012023 Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF…Senorx, Inc. · 2001
  3. Descendant · cites it directly · 29 of its ownK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  5. Descendant · 2 generations on · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  6. Descendant · 3 generations on · 26 of its ownK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
  7. Descendant · 4 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2002: 22005: 12006: 12007: 12010: 12014: 12015: 32016: 42017: 52018: 12019: 22020: 22021: 12022: 22024: 22025: 12026: 1
2002high 5 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 31 · See all
  • K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · cites it directly29descendants
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · 2 generations on28descendants
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · 2 generations on27descendants
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007 · 3 generations on26descendants
  • K102360Icesence 3IceCure Medical, Ltd. · 2010 · 4 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790187Bovie Hand ControlSybron Corp.1979—
0 (this device)K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.2001—
+1K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.20021
+2K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.2005—
+2K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.2006—
+3K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000…Sanarus Medical, Inc.2007—
+4K102360Icesence 3IceCure Medical, Ltd.20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200510
200610
200710
201010
201410
201530
201640
201750
201810
201920
202020
202110
202220
202420
202510
202610
FIG. 1 — Lineage of K012023, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KNW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KNW device

  1. #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K900903Kopans Hookwire Lesion Localization Needle
Summary page 1
…Lesion Localization Needle Biopsy Assistant PrecisionGuide Breast Lesion Localization Needle Bovie Hand Control Sure Core Biopsy Electrode Cook (K# unknown) Milex (K900903) Surgimedics (K# unknown) Becton-Dickinson (K881687/C) Sybron (K790187) Interventional Concepts, Inc. (K963813) S1 === Page…
Milex Products, Inc.1990—
Kept off the family treeK881687FDA’s K881687 is Cavitron Electrosurgical Module (Cem) and Pak
Our OCR of the scanned summary read K881687, FDA’s number for Cavitron Electrosurgical Module (Cem) and Pak (Cavitron Surgical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bovie Hand Control”. Kept off the family tree.
Summary page 1
…onGuide Breast Lesion Localization Needle Bovie Hand Control Sure Core Biopsy Electrode Cook (K# unknown) Milex (K900903) Surgimedics (K# unknown) Becton-Dickinson (K881687/C) Sybron (K790187) Interventional Concepts, Inc. (K963813) S1 Kofreo2 3 2/2 SenoRx Inc. Premarket Notificat…
Cavitron Surgical Systems1988—
*K790187Bovie Hand Control
Summary page 1
…n Localization Needle Bovie Hand Control Sure Core Biopsy Electrode Cook (K# unknown) Milex (K900903) Surgimedics (K# unknown) Becton-Dickinson (K881687/C) Sybron (K790187) Interventional Concepts, Inc. (K963813) S1 Kofreo2 3 2/2 SenoRx Inc. Premarket Notification v June 27, 2001…
Sybron Corp.1979—
*K963813Sure Core Biopsy Kit
Summary page 1
…Sure Core Biopsy Electrode Cook (K# unknown) Milex (K900903) Surgimedics (K# unknown) Becton-Dickinson (K881687/C) Sybron (K790187) Interventional Concepts, Inc. (K963813) S1 Kofreo2 3 2/2 SenoRx Inc. Premarket Notification v June 27, 2001 Anchor Guide™ Localization Device 4. DES…
Interventional Concepts, Inc.1997—
*—Kopans Breast Lesion Localization Needle
Named without a submission number
—
*—PrecisionGuide Breast Lesion Localization Needle
Named without a submission number
—

What descends from it? (31)

See all 31

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.200229
K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc.20020

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K022314 (Sanarus Medical, Inc., 2002) has gone furthest, with 29 descendants of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Senorx, Inc.

30 FDA decisions under this applicant name. See the company

  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast…Senorx, Inc. · 2023
  • K210654EnCor Breast Biopsy Probe with Rinse TubeSenorx, Inc. · 2021
  • K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. · 2016
  • K131654Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerSenorx, Inc. · 2013
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K012023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012023

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026