510(k) · Cleared
ClearedAuto Suture Site Marker Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GDW Staple, Implantable
Cleared on Feb 10, 1999 as substantially equivalent to K970817 (Biopsys Medical, Inc., 1997) after a 135-day review. Its family tree reaches back 1 generation to 1997. 35 later devices descend from it.
- Decided
- Feb 10, 1999
- Review
- 135 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970817 (1997). 35 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- This deviceK983400 Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999
- 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
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 |
|---|---|---|---|---|---|
| −1 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| 0 (this device) | K983400 | Auto Suture Site Marker Clip | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +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 |
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 |
|---|---|---|---|
| * | K970817 | Micromark ClipSummary page 1…2, 1998 CLASSIFICATION NAME: Implantable Staple COMMON NAME: Implantable Staple PROPRIETARY NAME: Auto Suture* Site Marker** staple PREDICATE DEVICES: MicroMark™ clip (K970817) DEVICE DESCRIPTION: The Auto Suture* Site Marker** staple, is a single use disposable staple, which consists of a non-absorbab… | 1997 |
What descends from it? (35)
See all 352 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?
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 Auto Suture* Site Marker** staple is intended for use in soft tissue during an open or
percutaneous biopsy procedure to radiographically mark the biopsy location.
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/K983400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983400: Auto Suture Site Marker Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983400
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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