510(k) · Cleared
ClearedTissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Uroscience, Inc. · GDW Staple, Implantable
Cleared on May 3, 2001 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 322 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 3 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- Descendant · cites it directly · 45 of its ownK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- Descendant · 2 generations on · 44 of its ownK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- Descendant · 3 generations on · 25 of its ownK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- Descendant · 4 generations on · 17 of its ownK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK012955 Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K032347Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003 · cites it directly45descendants
- K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004 · 2 generations on44descendants
- K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006 · 3 generations on25descendants
- K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007 · 4 generations on17descendants
- K012955Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| +1 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| +2 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| +3 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| +4 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| +1 | K012955 | Coaptite Tissue Marker and Coaptite FN Tissue Marker | Bioform, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 2 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
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.
2 devices in this family have a Class I recall. 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
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? (49)
See all 493 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K032347 (Carbon Medical Technologies, Inc., 2003) has gone furthest, with 45 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 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/K001807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001807: Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001807
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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