510(k) · Cleared
Recalled · 2004Mammotome EX Hand Held System
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 Feb 20, 2004 after an 87-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled once.
- Decided
- Feb 20, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK033700 Mammotome EX Hand Held SystemEthicon Endo-Surgery, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy…Devicor Medical Products, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK123259 Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK060384 Coramate/Spirotome SystemMedinvents · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK152989 Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc. · 2016 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012 · cites it directly3descendants
- K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc. · 2016 · 2 generations on2descendants
- K123259Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc. · 2012 · cites it directly2descendants
- K060384Coramate/Spirotome SystemMedinvents · 2006 · cites it directly2descendants
- K152989Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033700 | Mammotome EX Hand Held System | Ethicon Endo-Surgery, Inc. | 2004 | — |
| +1 | K112411 | Mammotome Elite Biopsy System | Devicor Medical Products, Inc. | 2012 | — |
| +2 | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G… | Devicor Medical Products, Inc. | 2016 | — |
| +1 | K123259 | Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) System | Devicor Medical Products, Inc. | 2012 | 1 |
| +1 | K060384 | Coramate/Spirotome System | Medinvents | 2006 | 1 |
| +1 | K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | Devicor Medical Products, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | — | Mammotome® Hand Held System Named without a submission number | |
| * | — | Mammotome® Hand Held 8 Gauge Probe Named without a submission number | |
| * | — | Mammotome® Biopsy System Named without a submission number |
What descends from it? (10)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2004 | Not classified | Z-0440-05 | Other | A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112411 (Devicor Medical Products, Inc., 2012) has gone furthest, with 3 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 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 Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot…
Read the full statement (205 words)
The Mammotome Biopsy System is indicated to provide 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 Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 as stated in the FDA summary.
https://510kreport.com/device/K033700 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033700: Mammotome EX Hand Held System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033700
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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