510(k) · Cleared

Cleared

Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007

K000060510(k) TraditionalCleared Mar 27, 200077-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

Senorx, Inc. · GDW Staple, Implantable

Cleared on Mar 27, 2000 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.

Decided: Mar 27, 2000
Review: 77 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 0

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

This deviceK000060 Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007Senorx, Inc. · 2000
Descendant · cites it directly · 21 of its ownK022326 Radiomed MarkerRadiomed Corporation · 2003
Descendant · 2 generations on · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
Descendant · cites it directly · 12 of its ownK012955 Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001
Descendant · 3 generations on · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
Descendant · 2 generations on · 10 of its ownK072219 Cytophil Tissue MarkerCytophil, Inc. · 2008

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2001high 5 (2012) · low 0 (2002)2026

Most influential descendants

Showing 5 of 35 · See all

K022326Radiomed MarkerRadiomed Corporation · 2003 · cites it directly21descendants
K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · 2 generations on20descendants
K012955Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001 · cites it directly12descendants
K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · 3 generations on11descendants
K072219Cytophil Tissue MarkerCytophil, Inc. · 2008 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000060	Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007	Senorx, Inc.	2000	—
+1	K022326	Radiomed Marker	Radiomed Corporation	2003	—
+2	K031206	Radiomed Soft Tissue Marker	Radiomed Corp.	2003	—
+1	K012955	Coaptite Tissue Marker and Coaptite FN Tissue Marker	Bioform, Inc.	2001	—
+3	K070305	Pre-Loaded Visicoil	Radiomed Corporation	2007	—
+2	K072219	Cytophil Tissue Marker	Cytophil, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	2	0
2007	2	0
2008	2	0
2009	1	0
2010	2	0
2011	1	0
2012	5	0
2013	3	0
2014	3	0
2015	3	0
2016	1	0
2017	4	0
2018	1	0
2020	1	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K000060, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K022326	Radiomed Marker	Radiomed Corporation	2003	21
K012955	Coaptite Tissue Marker and Coaptite FN Tissue Marker	Bioform, Inc.	2001	12

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, K022326 (Radiomed Corporation, 2003) has gone furthest, with 21 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

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

https://510kreport.com/device/K000060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000060: Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000060

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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