510(k) · Cleared
ClearedSuturtek Fastclose Suturing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suturtek Incorporated · GAL Suture, Absorbable, Natural
Cleared on Mar 17, 2003 as substantially equivalent to K011105 (Qrc Consulting, 2001) after a 54-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Mar 17, 2003
- Review
- 54 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011105 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011105 Suturtek Fastclose Fascia Closure DeviceQrc Consulting · 2001
- This deviceK030227 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
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 |
|---|---|---|---|---|---|
| −1 | K011105 | Suturtek Fastclose Fascia Closure Device | Qrc Consulting | 2001 | — |
| 0 (this device) | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K011105 | Suturtek Fastclose Fascia Closure Device | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032468 | Suturtek Fastclose Sternum Closure Device | 2003 | 1 |
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 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 | — |
What is it indicated for?
The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or
ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and
neurological procedures.
It is designed to aid in the prevention of suture needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030227: Suturtek Fastclose Suturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030227
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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