510(k) Report

510(k) · Cleared

Cleared

Easy Guide Electrosurgical Access Device

K012004510(k) TraditionalCleared Sep 25, 200190-day reviewClass II21 CFR 878.4400

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

Senorx, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 25, 2001 as substantially equivalent to K963813 (Interventional Concepts, Inc., 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it.

Decided
Sep 25, 2001
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

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

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1993: 1 other ancestor2002: 2 descendants clearedK790187 · Bovie Hand Control · Sybron Corp. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K790187 · Bovie Hand Control · Sybron Corp. · 19790
  1. Root · 1 generation backK790187 Bovie Hand ControlSybron Corp. · 1979
  2. This deviceK012004 Easy Guide Electrosurgical Access DeviceSenorx, Inc. · 2001
  3. Descendant · cites it directly · 1 of its ownK013641 Senorx Biopsy Device, Driver, Control Module, Including Accessories…Senorx, Inc. · 2002
  4. Descendant · 2 generations on · 0 of its ownK021707 Single Step Biopsy Device, Single Step Surgical Handle, Single Step…Senorx, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc. · 2002 · cites it directly1descendant
  • K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790187Bovie Hand ControlSybron Corp.1979—
0 (this device)K012004Easy Guide Electrosurgical Access DeviceSenorx, Inc.2001—
+1K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc.2002—
+2K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver…Senorx, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K012004, 1979–2002Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963813Sure Core Biopsy Kit
Summary page 1
…ies, 21 CFR 878.4400 IDENTIFICATION OF PREDICATE DEVICES Sure Core Biopsy Electrode Accucise Electrosurgical Trocar Bovie Hand Control Interventional Concepts, Inc. K963813 Applied Medical Resources K925984 Sybron Corporation K790187 S1 SenoRx Inc. Premarket Notification June 26,…
Interventional Concepts, Inc.1997—
*K925984Acucise Electrosurgical Trocar
Summary page 1
…N OF PREDICATE DEVICES Sure Core Biopsy Electrode Accucise Electrosurgical Trocar Bovie Hand Control Interventional Concepts, Inc. K963813 Applied Medical Resources K925984 Sybron Corporation K790187 S1 SenoRx Inc. Premarket Notification June 26, 2001 Easy Guide™ Electrosurgical A…
Applied Medical Resources1993—
*K790187Bovie Hand Control
Summary page 1
…Core Biopsy Electrode Accucise Electrosurgical Trocar Bovie Hand Control Interventional Concepts, Inc. K963813 Applied Medical Resources K925984 Sybron Corporation K790187 S1 SenoRx Inc. Premarket Notification June 26, 2001 Easy Guide™ Electrosurgical Access Device 4. DESCRIPTION…
Sybron Corp.1979—

Also cleared against K963813: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc.20021

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, K013641 (Senorx, Inc., 2002) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K963813.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Easy Guide™ Electrosurgical Access Device is indicated for use to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

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

Also cleared against K963813

1 other device cites the same predicate.

  • K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc. · 2001

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 GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K012004 · printed Nov 3, 2026

Cite this page

510(k) Report. “K012004: Easy Guide Electrosurgical Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012004

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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