510(k) Report

510(k) · Cleared

Cleared

Intact Breast Lesion Excision System and Advance

K060413510(k) TraditionalCleared Apr 27, 200670-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

Intact Medical Corporation · KNW Instrument, Biopsy

Cleared on Apr 27, 2006 as substantially equivalent to K003297 (Ethicon Endo-Surgery, Inc., 2001) after a 70-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.

Decided
Apr 27, 2006
Review
70 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K003297 (2001). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant clearedK003297 · Mammotome Hand Held Probe, Model MHH8 · Ethicon Endo-Surgery, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K003297 · Mammotome Hand Held Probe, Model MHH8 · Ethicon Endo-Surgery, Inc. · 20010
  1. Root · 1 generation backK003297 Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc. · 2001
  2. This deviceK060413 Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006
  3. Descendant · cites it directly · 3 of its ownK081057 Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008
  4. Descendant · cites it directly · 2 of its ownK142477 Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014
  5. Descendant · 2 generations on · 1 of its ownK152596 Intact® Gen2 SystemIntact Medical Corporation · 2016
  6. Descendant · 3 generations on · 0 of its ownK252183 Resitu Slider 09 (RESL09)Resitu Medical AB · 2025

Most influential descendants

Showing 4 of 4 · See all
  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008 · cites it directly3descendants
  • K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014 · cites it directly2descendants
  • K152596Intact® Gen2 SystemIntact Medical Corporation · 2016 · 2 generations on1descendant
  • K252183Resitu Slider 09 (RESL09)Resitu Medical AB · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003297Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc.2001—
0 (this device)K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation2006—
+1K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation2008—
+1K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation2014—
+2K152596Intact® Gen2 SystemIntact Medical Corporation2016—
+3K252183Resitu Slider 09 (RESL09)Resitu Medical AB2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201410
201610
202510
FIG. 1 — Lineage of K060413, 2001–2025Source: 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 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? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK003190FDA’s K003190 is EN Bloc Biopsy System
Our reading of the summary gave K003190, FDA’s number for EN Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…uite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM…
Neothermia Corp.200111
Kept off the family treeK021577FDA’s K021577 is Modification to EN-Bloc Biopsy System
Our reading of the summary gave K021577, FDA’s number for Modification to EN-Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is i…
Neothermia Corp.2002—
Kept off the family treeK020031FDA’s K020031 is EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006…
Our reading of the summary gave K020031, FDA’s number for EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001… (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…tick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is indicated…
Neothermia Corp.2002—
Kept off the family treeK042170FDA’s K042170 is EN-Bloc Biopsy System…
Our reading of the summary gave K042170, FDA’s number for EN-Bloc Biopsy System… (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…sachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is indicated to provid…
Neothermia Corporation2004—
Kept off the family treeK050737FDA’s K050737 is Neothermia EN-Bloc Biopsy System
Our reading of the summary gave K050737, FDA’s number for Neothermia EN-Bloc Biopsy System (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…s 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is indicated to provide tissue…
Neothermia Corporation2005—
Kept off the family treeK052246FDA’s K052246 is Modification to EN-Bloc Biopsy System
Our reading of the summary gave K052246, FDA’s number for Modification to EN-Bloc Biopsy System (Neothermia Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intact Medical Corporation's intact Tm BLES”. Kept off the family tree.
Summary page 1
…Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is indicated to provide tissue samples for d…
Neothermia Corporation2005—
*K003297Mammotome Hand Held Probe, Model MHH8
Summary page 1
…55-6239 Predicate Devices Intact Medical Corporation's intact Tm BLES (K003190, K021577, K020031, K042170, K050737, and K052246) and the Ethicon Endo-Surgery Mammotome (K003297). Intended Use The intact TM BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The…
Ethicon Endo-Surgery, Inc.2001—

Also cleared against K003297: 7 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation20083
K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation20142

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?

  • Its one ancestor has no recall.
  • Of its descendants, K081057 (Intact Medical Corporation, 2008) has gone furthest, with 3 descendants of its own.
  • 7 other devices also cite its predicate K003297.

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)—

What is it indicated for?

The intact TM BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The intactTM BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The intactTM BLES 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…

Read the full statement (202 words)

The intact TM BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The intactTM BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The intactTM BLES 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 palpable 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 intact BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic 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.

Also cleared against K003297

7 other devices cite the same predicate.

  • K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009
  • K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc. · 2009
  • K040087RabbitScion International, Inc. · 2004
  • K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003
  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002

More from Intact Medical Corporation

4 FDA decisions under this applicant name. See the company

  • K152596Intact® Gen2 SystemIntact Medical Corporation · 2016
  • K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014
  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008

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/K060413 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060413: Intact Breast Lesion Excision System and Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060413

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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