510(k) Report

510(k) · Cleared

Cleared

BEXCORE Breast Biopsy System, Biopsy Needle

K171890510(k) TraditionalCleared Aug 20, 2018420-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

Medical Park Co., Ltd. · KNW Instrument, Biopsy

Cleared on Aug 20, 2018 as substantially equivalent to K093512 (Senorx, Inc., 2009) after a 420-day review. Its family tree reaches back 3 generations to 1999.

Decided
Aug 20, 2018
Review
420 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K991980 (1999). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestorReference device: K140137 · Safety Biopsy Needle System · Pfm Medical, Inc. · 2014K991980 · Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch, · Ethicon Endo-Surgery, Inc. · 1999K030472 · Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System · Ethicon Endo-Surgery, Inc. · 2003K093512 · Encor Breast Biopsy System · Senorx, Inc. · 2009199520002005201020152020
Other ancestors, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor K093512 · Encor Breast Biopsy System · Senorx, Inc. · 2009K030472 · Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System · Ethicon Endo-Surgery, Inc. · 2003K991980 · Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch, · Ethicon Endo-Surgery, Inc. · 19990
  1. Root · 3 generations backK991980 Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH…Ethicon Endo-Surgery, Inc. · 1999
  2. 2 generations backK030472 Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc. · 2003
  3. 1 generation backK093512 Encor Breast Biopsy SystemSenorx, Inc. · 2009
  4. This deviceK171890 BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K991980Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster…Ethicon Endo-Surgery, Inc.1999—
−2K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc.2003—
−1K093512Encor Breast Biopsy SystemSenorx, Inc.2009—
0 (this device)K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200410
200510
FIG. 1 — Lineage of K171890, 1999–2018Source: 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? (1)

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
*K093512Encor Breast Biopsy System
Summary page 4
…s II III. PREDICATE DEVICE Primary Manufacturer SenoRx, Inc Device Name EnCor Breast Biopsy System 510(k) Number K093512(Decision Date – Nov 20, 2009) Regulation Name Gastroenterology-urology biopsy instrument Regulation Number…
Senorx, Inc.2009—
†K140137Safety Biopsy Needle SystemPfm Medical, Inc.2014—

Also cleared against K093512: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K093512.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 BEXCORE Vacuum Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. - It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. - It 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…

Read the full statement (208 words)

The BEXCORE Vacuum Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

- It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

- It 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 BEXCORE Vacuum Assisted Breast 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K093512

2 other devices cite the same predicate.

  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast…Senorx, Inc. · 2023
  • K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc. · 2011

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/K171890 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171890: BEXCORE Breast Biopsy System, Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171890

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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