510(k) · Cleared

Cleared

Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP

K080698510(k) SpecialCleared Mar 31, 200819-day reviewClass II21 CFR 878.4300

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

Senorx, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Mar 31, 2008 as substantially equivalent to K011402 (Senorx, Inc., 2001) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Mar 31, 2008
Review: 19 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K011402 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011402 Biopsy Site MarkerSenorx, Inc. · 2001
This deviceK080698 Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGPSenorx, Inc. · 2008
Descendant · cites it directly · 0 of its ownK081170 Prostate Tissue MarkerSenorx, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K081170Prostate Tissue MarkerSenorx, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011402	Biopsy Site Marker	Senorx, Inc.	2001	—
0 (this device)	K080698	Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP	Senorx, Inc.	2008	—
+1	K081170	Prostate Tissue Marker	Senorx, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K080698, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NEU? 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 NEU device

#1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011402	Biopsy Site Marker	Senorx, Inc.	2001	—
*	K040706	Gel Mark IV Summary page 1 …regulation 878.4300 NEU Predicate device Biopsy Site Marker; KOl 1402; clearance date 7/16/2001; FZP Gel Mark IV Tissue Marker, K040706, clearance date 4/8/2004, NEU Description The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposab…	Senorx, Inc.	2004	—

Also cleared against K011402: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081170	Prostate Tissue Marker	Senorx, Inc.	2008	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K081170 (Senorx, Inc., 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011402.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NEU

5in 2025

2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007high 267 (2024) · low 46 (2021)2026

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

Recalls per year · NEU

2in 2025

2007high 2 (2024) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NEU

411in 2025

2007high 411 (2025) · low 5 (2007)2025

MAUDE reports naming product code NEU, 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	4	94	0	5
2008	7	107	0	5
2009	4	70	0	30
2010	5	69	0	12
2011	3	145	1	18
2012	3	120	0	54
2013	7	49	0	60
2014	3	48	0	38
2015	7	111	0	120
2016	2	—	0	56
2017	4	115	1	69
2018	8	89	0	66
2019	5	149	0	58
2020	3	169	0	45
2021	3	46	0	82
2022	2	—	1	100
2023	4	136	0	142
2024	10	267	2 (1)	247
2025	5	99	2	411
2026	1	—	2	—

What is it indicated for?

The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080698 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080698: Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080698

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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