510(k) Report

510(k) · Cleared

Cleared

Sure Core Biopsy Kit

K963813510(k) TraditionalCleared Mar 20, 1997178-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

Interventional Concepts, Inc. · KNW Instrument, Biopsy

Cleared on Mar 20, 1997 after a 178-day review. The FDA summary names no predicate by number. 34 later devices descend from it.

Decided
Mar 20, 1997
Review
178 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

34 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2002: 3 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2019: 2 descendants cleared2015: 3 descendants cleared2024: 2 descendants cleared2016: 4 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared2017: 5 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 2 descendants cleared1995200020052010201520202025
  1. This deviceK963813 Sure Core Biopsy KitInterventional Concepts, Inc. · 1997
  2. Descendant · cites it directly · 31 of its ownK012023 Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF…Senorx, Inc. · 2001
  3. Descendant · 2 generations on · 29 of its ownK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  5. Descendant · 3 generations on · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  6. Descendant · 4 generations on · 26 of its ownK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2001: 22002: 32005: 12006: 12007: 12010: 12014: 12015: 32016: 42017: 52018: 12019: 22020: 22021: 12022: 22024: 22025: 12026: 1
2001high 5 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 34 · See all
  • K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc. · 2001 · cites it directly31descendants
  • K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · 2 generations on29descendants
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · 3 generations on28descendants
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · 3 generations on27descendants
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007 · 4 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963813Sure Core Biopsy KitInterventional Concepts, Inc.1997—
+1K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.2001—
+2K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.20021
+3K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.2005—
+3K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.2006—
+4K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000…Sanarus Medical, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200230
200510
200610
200710
201010
201410
201530
201640
201750
201810
201920
202020
202110
202220
202420
202510
202610
FIG. 1 — Lineage of K963813, 1997–2026Source: 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), 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?

The FDA summary names no predicate by number.

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.200131
K012004Easy Guide Electrosurgical Access DeviceSenorx, Inc.20012

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, K012023 (Senorx, Inc., 2001) has gone furthest, with 31 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)—

What is it indicated for?

used to cut soft tissue for the purpose of obtain a biopsy sample

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K963813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963813: Sure Core Biopsy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963813

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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