510(k) · Cleared
ClearedSenorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and Footswitch), Vacuums
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 29, 2002 as substantially equivalent to K991980 (Ethicon Endo-Surgery, Inc., 1999) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1979. 1 later device descends from it.
- Decided
- Jan 29, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K790187 (1979). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK790187 Bovie Hand ControlSybron Corp. · 1979
- 1 generation backK012004 Easy Guide Electrosurgical Access DeviceSenorx, Inc. · 2001
- This deviceK013641 Senorx Biopsy Device, Driver, Control Module, Including Accessories…Senorx, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK021707 Single Step Biopsy Device, Single Step Surgical Handle, Single Step…Senorx, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790187 | Bovie Hand Control | Sybron Corp. | 1979 | — |
| −1 | K012004 | Easy Guide Electrosurgical Access Device | Senorx, Inc. | 2001 | — |
| 0 (this device) | K013641 | Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power… | Senorx, Inc. | 2002 | — |
| +1 | K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver… | Senorx, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991980 | Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and…Summary page 1…noRx Control Module SenoRxVacuum System b. Classification Name: Biopsy Device, 876.1075 3. IDENTIFICATION OF PREDICATE DEVICES Mammotome® Biopsy Ethicon Endo-Surgery (K991980, System K003297) o Easy Guide™ SenoRx Inc. (K012004) Electrosurgical Access Device S1 SenoRx Inc. Premarket Not… | 1999 |
| * | K003297 | Mammotome Hand Held Probe, Model MHH8Summary page 1…ule SenoRxVacuum System b. Classification Name: Biopsy Device, 876.1075 3. IDENTIFICATION OF PREDICATE DEVICES Mammotome® Biopsy Ethicon Endo-Surgery (K991980, System K003297) o Easy Guide™ SenoRx Inc. (K012004) Electrosurgical Access Device S1 SenoRx Inc. Premarket Notification k G, /… | 2001 |
| * | K012004 | Easy Guide Electrosurgical Access DeviceSummary page 1…cation Name: Biopsy Device, 876.1075 3. IDENTIFICATION OF PREDICATE DEVICES Mammotome® Biopsy Ethicon Endo-Surgery (K991980, System K003297) o Easy Guide™ SenoRx Inc. (K012004) Electrosurgical Access Device S1 SenoRx Inc. Premarket Notification k G, / 3( c([ 2 / > SenoRx Biopsy Device… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step… | 2002 | 0 |
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 22.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K021707 (Senorx, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K991980.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013641: Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and Footswitch), Vacuums.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013641
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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