510(k) Report

510(k) · Cleared

Cleared

Mammotome Hand Held Probe, Model MHH8

K003297510(k) TraditionalCleared Jan 18, 200190-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

Ethicon Endo-Surgery, Inc. · KNW Instrument, Biopsy

Cleared on Jan 18, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Jan 18, 2001
Review
90 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

27 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2002: 3 descendants cleared2014: 2 descendants cleared2009: 2 descendants cleared2006: 1 descendant cleared2018: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2023: 1 descendant cleared2011: 1 descendant cleared2007: 1 descendant cleared2019: 1 descendant cleared2016: 2 descendants cleared2025: 2 descendants cleared2022: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003297 Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK093068 Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe…C.R. Bard, Inc. · 2009
  3. Descendant · cites it directly · 5 of its ownK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
  4. Descendant · cites it directly · 4 of its ownK060413 Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006
  5. Descendant · cites it directly · 4 of its ownK024089 Vacuflash Biopsy SystemBip USA, Inc. · 2003
  6. Descendant · 2 generations on · 3 of its ownK112411 Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12004: 12005: 12006: 12007: 12008: 12009: 22010: 12011: 12012: 12014: 22016: 22018: 22019: 12021: 12022: 12023: 12025: 22026: 1
2002high 3 (2002) · low 0 (2013)2026

Most influential descendants

Showing 5 of 27 · See all
  • K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc. · 2009 · cites it directly7descendants
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009 · cites it directly5descendants
  • K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006 · cites it directly4descendants
  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003 · cites it directly4descendants
  • K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003297Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc.2001—
+1K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk…C.R. Bard, Inc.2009—
+1K093512Encor Breast Biopsy SystemSenorx, Inc.2009—
+1K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation2006—
+1K024089Vacuflash Biopsy SystemBip USA, Inc.2003—
+2K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200410
200510
200610
200710
200810
200920
201010
201110
201210
201420
201620
201820
201910
202110
202210
202310
202520
202610
FIG. 1 — Lineage of K003297, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc.20097
K093512Encor Breast Biopsy SystemSenorx, Inc.20095
K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation20064
K024089Vacuflash Biopsy SystemBip USA, Inc.20034
K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc.20021
K133702Presto Breast Biopsy DeviceSontina Medical, LLC20140
K040087RabbitScion International, Inc.20040
K020024Caris Minitome Biopsy InstrumentArtemis Medical, 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?

  • Of its descendants, K093068 (C.R. Bard, Inc., 2009) has gone furthest, with 7 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)—

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

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/K003297 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003297: Mammotome Hand Held Probe, Model MHH8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003297

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026