510(k) · Cleared
Cleared11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,Housing, Ult
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · KNW Instrument, Biopsy
Cleared on Nov 18, 1999 after a 90-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK992813 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge…Ethicon Endo-Surgery, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK111100 Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast…Senorx, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003 · cites it directly7descendants
- K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009 · 2 generations on5descendants
- K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011 · 3 generations on3descendants
- K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc. · 2023 · 3 generations on2descendants
- K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992813 | 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +1 | K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System | Ethicon Endo-Surgery, Inc. | 2003 | — |
| +2 | K093512 | Encor Breast Biopsy System | Senorx, Inc. | 2009 | — |
| +3 | K111100 | Encor Enspire Breast Biopsy System | C.R. Bard, Inc. | 2011 | — |
| +3 | K233220 | EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver… | Senorx, Inc. | 2023 | — |
| +4 | K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Mammotome® Biopsy System Named without a submission number | |
| * | — | Powered Suction Pump Named without a submission number | |
| * | — | Tubing Clamp and Tubing Accessory Named without a submission number | |
| * | — | Arm Clamp Named without a submission number |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K030472 (Ethicon Endo-Surgery, Inc., 2003) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The Mammotome® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does…
Read the full statement (103 words)
The Mammotome® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a 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/K992813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992813: 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,Housing, Ult.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992813
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026