510(k) Report

510(k) · Cleared

Cleared

15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device

K993936510(k) TraditionalCleared Dec 27, 199938-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

Imagyn Surgical · KNW Instrument, Biopsy

Cleared on Dec 27, 1999 after a 38-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.

Decided
Dec 27, 1999
Review
38 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared1995200020052010201520202025
  1. This deviceK993936 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy…Imagyn Surgical · 1999
  2. Descendant · cites it directly · 1 of its ownK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
  3. Descendant · 2 generations on · 0 of its ownK040087 RabbitScion International, Inc. · 2004
  4. Descendant · cites it directly · 0 of its ownK020024 Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001 · cites it directly1descendant
  • K040087RabbitScion International, Inc. · 2004 · 2 generations on0descendants
  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K99393615MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device…Imagyn Surgical1999—
+1K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical2001—
+2K040087RabbitScion International, Inc.2004—
+1K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200410
FIG. 1 — Lineage of K993936, 1999–2004Source: 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
*—Imagyn Surgical SiteSelect devices
Named without a submission number
—
*—USSC ABBI device
Named without a submission number
—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical20011
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, K011575 (Imagyn Surgical, 2001) has gone furthest, with 1 descendant 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?

SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's…

Read the full statement (147 words)

SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's mammographic appearance. Therefore, it is essential that ihe tissue margins be examined for margin involvement and-completeness of removal in cases where the tissue sample is not found to be benign.

SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue.

This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

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

More from Imagyn Surgical

3 FDA decisions under this applicant name. See the company

  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
  • K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001

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/K993936 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993936

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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