510(k) Report

510(k) · Cleared

Cleared

Intact Advance and Intact Excision XL, Intact BLES

K142477510(k) TraditionalCleared Dec 15, 2014103-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 Dec 15, 2014 as substantially equivalent to K060413 (Intact Medical Corporation, 2006) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.

Decided
Dec 15, 2014
Review
103 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K003297 (2001). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2025: 1 descendant clearedK003297 · Mammotome Hand Held Probe, Model MHH8 · Ethicon Endo-Surgery, Inc. · 2001K060413 · Intact Breast Lesion Excision System and Advance · Intact Medical Corporation · 2006K081057 · Intact Breast Lesion Excision System with Intact Excision XL · Intact Medical Corporation · 2008200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K081057 · Intact Breast Lesion Excision System with Intact Excision XL · Intact Medical Corporation · 2008K060413 · Intact Breast Lesion Excision System and Advance · Intact Medical Corporation · 2006K003297 · Mammotome Hand Held Probe, Model MHH8 · Ethicon Endo-Surgery, Inc. · 20010
  1. Root · 3 generations backK003297 Mammotome Hand Held Probe, Model MHH8Ethicon Endo-Surgery, Inc. · 2001
  2. 2 generations backK060413 Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006
  3. 1 generation backK081057 Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008
  4. This deviceK142477 Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014
  5. Descendant · cites it directly · 1 of its ownK152596 Intact® Gen2 SystemIntact Medical Corporation · 2016
  6. Descendant · 2 generations on · 0 of its ownK252183 Resitu Slider 09 (RESL09)Resitu Medical AB · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K152596Intact® Gen2 SystemIntact Medical Corporation · 2016 · cites it directly1descendant
  • K252183Resitu Slider 09 (RESL09)Resitu Medical AB · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202510
FIG. 1 — Lineage of K142477, 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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K060413Intact Breast Lesion Excision System and Advance
Summary page 4
…® Predicate Devices 10mm, 12mm, 15mm and 20mm Intact BLES (K060413) manufactured by Intact Medical Corporation ®…
Intact Medical Corporation2006—
*K081057Intact Breast Lesion Excision System with Intact Excision XL
Summary page 4
…poration ® Intact Advance and Intact Excision XL (K081057 “Primary Predicate”) manufactured by Intact Medical…
Intact Medical Corporation2008—

Also cleared against K060413: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152596Intact® Gen2 SystemIntact Medical Corporation20161

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 13 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K152596 (Intact Medical Corporation, 2016) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K060413.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with…

Read the full statement (252 words)

The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities

The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality

The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality

The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12–30mm

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 with Intact® Excision XL wand and handle 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 K060413

1 other device cites the same predicate.

  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008

More from Intact Medical Corporation

4 FDA decisions under this applicant name. See the company

  • K152596Intact® Gen2 SystemIntact Medical Corporation · 2016
  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008
  • K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006

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/K142477 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142477: Intact Advance and Intact Excision XL, Intact BLES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142477

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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