510(k) Report

510(k) · Cleared

Cleared

Biopsy Sciences, LLC, Lung Biopsy Site Marker

K041331510(k) TraditionalCleared Jun 15, 200427-day reviewClass II21 CFR 878.4750

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

Biopsy Sciences, LLC · GDW Staple, Implantable

Cleared on Jun 15, 2004 after a 27-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.

Decided
Jun 15, 2004
Review
27 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2018: 2 descendants cleared2006: 1 descendant cleared2019: 1 descendant cleared2009: 2 descendants cleared2012: 1 descendant cleared2013: 3 descendants cleared2021: 3 descendants cleared2016: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants cleared2023: 5 descendants cleared2024: 5 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK041331 Biopsy Sciences, LLC, Lung Biopsy Site MarkerBiopsy Sciences, LLC · 2004
  2. Descendant · cites it directly · 30 of its ownK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  3. Descendant · 2 generations on · 28 of its ownK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  4. Descendant · 2 generations on · 27 of its ownK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
  5. Descendant · 3 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
  6. Descendant · 4 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2006: 12009: 22012: 12013: 32016: 22017: 22018: 22019: 12020: 12021: 32022: 22023: 52024: 52025: 12026: 1
2006high 5 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 32 · See all
  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006 · cites it directly30descendants
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009 · 2 generations on28descendants
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC · 2009 · 2 generations on27descendants
  • K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 3 generations on15descendants
  • K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041331Biopsy Sciences, LLC, Lung Biopsy Site MarkerBiopsy Sciences, LLC2004—
+1K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC2006—
+2K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC2009—
+2K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC2009—
+3K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical2013—
+4K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200920
201210
201330
201620
201720
201820
201910
202010
202130
202220
202350
202450
202510
202610
FIG. 1 — Lineage of K041331, 2004–2026Source: 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), 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 GDW? 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 GDW device

  1. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 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? (6)

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
*—Biopsy Sciences Bio-MARK Biopsy Site Marker
Named without a submission number
—
*—J&J Ethicon MicroMark
Named without a submission number
—
*—SenoRx Gel Mark Biopsy Site Marker
Named without a submission number
—
*—Artemis CoreMARK/MegaMARK Biopsy Site Identifier
Named without a submission number
—
*—Vivant Medical Biopsy Marker System
Named without a submission number
—
*—Medical Device Technologies Aspiration and Injection Needle
Named without a submission number
—

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC200630
K180175SignalMark Lung Biopsy Site MarkerView Point Medical, Inc.20180

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, K060769 (Biopsy Sciences, LLC, 2006) has gone furthest, with 30 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, 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
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

What is it indicated for?

The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Indications for use as stated in the FDA summary.

More from Biopsy Sciences, LLC

8 FDA decisions under this applicant name. See the company

  • K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
  • K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1…Biopsy Sciences, LLC · 2009
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K041331 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041331

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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