510(k) · Cleared
ClearedAnchor Band Suturing System, Model SR-AB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anulex Technologies, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jul 5, 2006 as substantially equivalent to K042031 (Opus Medical, Inc., 2004) and 2 other predicates after a 48-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it.
- Decided
- Jul 5, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930738 (1994). 4 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 1 generation backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- This deviceK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK100572 Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006 · cites it directly9descendants
- K100572Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010 · cites it directly7descendants
- K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009 · 2 generations on7descendants
- K111462Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on6descendants
- K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −1 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| 0 (this device) | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| +1 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| +1 | K100572 | Versaclose, Model VC-200-01 | Anulex Technologies, Inc. | 2010 | — |
| +2 | K091432 | Xclose Tissue Repair System, Model XC-200-01 | Anulex Technologies, Inc. | 2009 | — |
| +2 | K111462 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| +3 | K112849 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K042031 | Opus Speedstitch Suture DeviceSummary page 1…the following predicate devices: * ArthroCare Speedstitch (K042031 cleared October 19, 2004) * AutoSuture SurgiStitch… | 2004 |
| * | K972911 | Auto Suture*Endostitch* II** Suture ApplierSummary page 1…(K042031 cleared October 19, 2004) * AutoSuture SurgiStitch (K97291 1 cleared April 25, 1998) * Teleflex Medical Polyester Nonabsorbable Suture… | 1998 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 1…(K97291 1 cleared April 25, 1998) * Teleflex Medical Polyester Nonabsorbable Suture (K021019 cleared June 18, 2002) Device Description: The Anchor Band Suturing System consists of a non-absorbable… | 2002 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K062307 (Anulex Technologies, Inc., 2006) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K042031.
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?
The Anchor Band Suturing System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061386: Anchor Band Suturing System, Model SR-AB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061386
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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