510(k) · Cleared
Recalled · Class II · 2018Insorb Absorbalbe Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incisive Surgical, Inc. · GDW Staple, Implantable
Cleared on Mar 16, 2012 after a 39-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 16, 2012
- Review
- 39 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 2
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK120373 Insorb Absorbalbe StapleIncisive Surgical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131563 Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K131563Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120373 | Insorb Absorbalbe Staple | Incisive Surgical, Inc. | 2012 | — |
| +1 | K131563 | Subq IT! Bioabsorbable Skin Closure System | Opus Ksd, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K090159 | FDA’s K090159 is Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131563 | Subq IT! Bioabsorbable Skin Closure System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2018 | Class II | Z-0078-2019 | Process control | Possible compromise of the sterile barrier integrity |
| Mar 19, 2015 | Class II | Z-1545-2015 | Labeling False and Misleading | A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131563 (Opus Ksd, Inc., 2014) has gone furthest, with 0 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. 2012, this device’s year, is highlighted.
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?
Synthetic absorbable INSORB staples are intended for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120373: Insorb Absorbalbe Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120373
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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