510(k) · Cleared
Recalled · Class II · 2015Insorb Absorbable Staple, Model SP-B20
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 Dec 16, 2003 as substantially equivalent to K024117 (Incisive Surgical, Inc., 2003) after a 32-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915489 (1992). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915489 Auto Suture Absorable Subcuticular Closure StapleUnited States Surgical, A Division of Tyco Healthc · 1992
- 1 generation backK024117 Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · Recalled
- This deviceK033602 Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK061784 Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK131563 Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915489 | Auto Suture Absorable Subcuticular Closure Staple | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| −1 | K024117 | Insorb Absorbable Staples, Model SP-B20 | Incisive Surgical, Inc. | 2003 | 1 |
| 0 (this device) | K033602 | Insorb Absorbable Staple, Model SP-B20 | Incisive Surgical, Inc. | 2003 | — |
| +1 | K061784 | Insorb Absorbable Staple, Model 1020 | Incisive Surgical, Inc. | 2006 | 1 |
| +1 | K131563 | Subq IT! Bioabsorbable Skin Closure System | Opus Ksd, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024117 | Insorb Absorbable Staples, Model SP-B20Summary page 1…R 8787.4750, Staple, Implantable and Number: Product Code: GDW Predicate Device INSORB TM Absorbable Staple Name and 510(k) K024117 Number Device Description: INSORB TM Absorbable Staples are 5 mm in length, 0.8 mm thic… | 2003 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K061784 (Incisive Surgical, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K024117.
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?
Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery 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/K033602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033602: Insorb Absorbable Staple, Model SP-B20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033602
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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