510(k) · Cleared
Recalled · 2011Opus Speedstitch Suture Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opus Medical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Oct 19, 2004 after an 83-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK042031 Opus Speedstitch Suture DeviceOpus Medical, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK100572 Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006 · cites it directly11descendants
- K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006 · 2 generations on9descendants
- K100572Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010 · 2 generations on7descendants
- K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009 · 3 generations on7descendants
- K111462Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042031 | Opus Speedstitch Suture Device | Opus Medical, Inc. | 2004 | — |
| +1 | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| +2 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| +2 | K100572 | Versaclose, Model VC-200-01 | Anulex Technologies, Inc. | 2010 | — |
| +3 | K091432 | Xclose Tissue Repair System, Model XC-200-01 | Anulex Technologies, Inc. | 2009 | — |
| +3 | K111462 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | — | Opus SmartStitch® Suture Device Named without a submission number |
What descends from it? (14)
See all 143 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 |
|---|---|---|---|---|
| Aug 8, 2011 | Not classified | Z-0611-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061386 (Anulex Technologies, Inc., 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042031: Opus Speedstitch Suture Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042031
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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