510(k) Report

510(k) · Cleared

Cleared

Kopans Hookwire Lesion Localization Needle

K900903510(k) TraditionalCleared May 3, 199065-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Milex Products, Inc. · GDF Guide, Needle, Surgical

Cleared on May 3, 1990 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided
May 3, 1990
Review
65 days
Class
Class I
Product code
GDF
Recalls
None
Predicates
0

32 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 2 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 cleared1990200020102020
  1. This deviceK900903 Kopans Hookwire Lesion Localization NeedleMilex Products, Inc. · 1990
  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 32 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22005: 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 32 · 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)K900903Kopans Hookwire Lesion Localization NeedleMilex Products, Inc.1990—
+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
200110
200220
200510
200610
200710
201010
201410
201530
201640
201750
201810
201920
202020
202110
202220
202420
202510
202610
FIG. 1 — Lineage of K900903, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GDF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (32)

See all 32

1 later device cites 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

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 GDF devices

GDF Guide, Needle, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDF

FDA has decided no GDF device since 2007.

Median 510(k) review, days · GDF

Too few GDF 510(k)s in any year since 2007 to give a median.

Recalls per year · GDF

4in 2016

2007: 62009: 12010: 12016: 4
2007high 6 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GDF

19in 2025

2007: 92008: 22009: 62010: 62011: 92012: 102013: 92014: 72015: 182016: 152017: 62018: 72019: 132020: 142021: 92022: 42023: 132024: 162025: 19
2007high 19 (2025) · low 2 (2008)2025

MAUDE reports naming product code GDF, 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
20070—69
20080—02
20090—16
20100—16
20110—09
20120—010
20130—09
20140—07
20150—018
20160—415
20170—06
20180—07
20190—013
20200—014
20210—09
20220—04
20230—013
20240—016
20250—019
20260—0—

More from Milex Products, Inc.

8 FDA decisions under this applicant name. See the company

  • K001545Pipet CuretMilex Products, Inc. · 2000
  • K904774Inglat-O-BallMilex Products, Inc. · 199015 recalls
  • K904026Inflat-O-BallMilex Products, Inc. · 199013 recalls
  • K882628Endo C BrushMilex Products, Inc. · 1988
  • K862410Milex Kegel Perineal ExerciserMilex Products, Inc. · 1986

Recent decisions in GDF

The GDF category page

  • K031173Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc. · 2003
  • K950311Global Medical Products Brest Lesion Localization Needle with Stiffened WireGlobal Medical Products, Ltd. · 1995
  • K950007Surgical Instrument GuideUnited States Surgical, A Division of Tyco Healthc · 1995
  • K945124Breast Lesion Localization NeedlePromex, Inc. · 1994
  • K944942Breast Lesion Localization NeedlePromedical, Ltd. · 1994

https://510kreport.com/device/K900903 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900903: Kopans Hookwire Lesion Localization Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900903

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026