510(k) · Cleared
ClearedMicromark Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopsys Medical, Inc. · GDW Staple, Implantable
Cleared on Sep 11, 1997 after a 189-day review. The FDA summary names its predicate without a number. 78 later devices descend from it.
- Decided
- Sep 11, 1997
- Review
- 189 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 0
78 later devices descend from it, 4 citing it directly.
- This deviceK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- Descendant · cites it directly · 35 of its ownK983400 Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999
- Descendant · cites it directly · 30 of its ownK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
- Descendant · 2 generations on · 28 of its ownK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
- Descendant · cites it directly · 28 of its ownK993785 Ultraclip Tissue MarkerInrad · 2000 · Recalled
- Descendant · 2 generations on · 27 of its ownK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K983400Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999 · cites it directly35descendants
- K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006 · cites it directly30descendants
- K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009 · 2 generations on28descendants
- K993785Ultraclip Tissue MarkerInrad · 2000 · cites it directly28descendants
- K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC · 2009 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| +1 | K983400 | Auto Suture Site Marker Clip | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +1 | K060769 | Hydromark Biopsy Site Marker | Biopsy Sciences, LLC | 2006 | — |
| +2 | K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2009 | — |
| +1 | K993785 | Ultraclip Tissue Marker | Inrad | 2000 | 1 |
| +2 | K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… | Biopsy Sciences, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 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? (1)
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 | Decided |
|---|---|---|---|
| * | — | BMI Surgical Staple Marker Named without a submission number |
What descends from it? (78)
See all 784 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K983400 (United States Surgical, A Division of Tyco Healthc, 1999) has gone furthest, with 35 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 | — |
What is it indicated for?
The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.
It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970817: Micromark Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970817
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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