510(k) · Cleared
ClearedSuturtek Fastclose Fascia Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qrc Consulting · GAL Suture, Absorbable, Natural
Cleared on May 30, 2001 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 30, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK011105 Suturtek Fastclose Fascia Closure DeviceQrc Consulting · 2001
- Descendant · cites it directly · 2 of its ownK030227 Suturtek Fastclose Suturing DeviceSuturtek Incorporated · 2003
- Descendant · cites it directly · 1 of its ownK032468 Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003
- Descendant · 2 generations on · 0 of its ownK082828 Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008
- Descendant · cites it directly · 0 of its ownK063462 Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK042897 Autobahn Tissue Closure Device and Disposable CartridgeEthicon Endo-Surgery, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K030227Suturtek Fastclose Suturing DeviceSuturtek Incorporated · 2003 · cites it directly2descendants
- K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003 · cites it directly1descendant
- K082828Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008 · 2 generations on0descendants
- K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007 · cites it directly0descendants
- K042897Autobahn Tissue Closure Device and Disposable CartridgeEthicon Endo-Surgery, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011105 | Suturtek Fastclose Fascia Closure Device | Qrc Consulting | 2001 | — |
| +1 | K030227 | Suturtek Fastclose Suturing Device | Suturtek Incorporated | 2003 | — |
| +1 | K032468 | Suturtek Fastclose Sternum Closure Device | Suturtek Incorporated | 2003 | — |
| +2 | K082828 | Suturtek 360 Degree Sternal Closure Device | Suturtek Incorporated | 2008 | — |
| +1 | K063462 | Neatstitch Neatclose Suturing Device | Neat Stitch, Ltd. | 2007 | — |
| +1 | K042897 | Autobahn Tissue Closure Device and Disposable Cartridge | Ethicon Endo-Surgery, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 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.
Planning a device in GAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (5)
4 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, K030227 (Suturtek Incorporated, 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GAL
Too few GAL 510(k)s in any year since 2007 to give a median.
Recalls per year · GAL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAL
117in 2025
MAUDE reports naming product code GAL, 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 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 57 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 157 |
| 2015 | 1 | — | 0 | 137 |
| 2016 | 0 | — | 0 | 87 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 0 | — | 0 | 246 |
| 2019 | 0 | — | 1 | 229 |
| 2020 | 0 | — | 0 | 109 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 130 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 117 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011105: Suturtek Fastclose Fascia Closure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011105
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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