510(k) Report

510(k) · Cleared

Cleared

Xclose Tissue Repair System, Model SRS

K062307510(k) SpecialCleared Sep 1, 200624-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Anulex Technologies, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Sep 1, 2006 as substantially equivalent to K061386 (Anulex Technologies, Inc., 2006) after a 24-day review. Its family tree reaches back 3 generations to 1994. 9 later devices descend from it.

Decided
Sep 1, 2006
Review
24 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K930738 (1994). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1998: 1 other ancestor2009: 2 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant clearedK930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalledK021019 · Cottony II, Silky II Polydek & Tevdek II Polyester Suture · Genzyme Corp. · 2002 · recalledK061386 · Anchor Band Suturing System, Model SR-AB · Anulex Technologies, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K061386 · Anchor Band Suturing System, Model SR-AB · Anulex Technologies, Inc. · 2006K021019 · Cottony II, Silky II Polydek & Tevdek II Polyester Suture · Genzyme Corp. · 2002 · recalledK930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalled0+5
  1. Root · 3 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
  2. 2 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
  3. 1 generation backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
  4. This deviceK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
  5. Descendant · cites it directly · 7 of its ownK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
  6. Descendant · 2 generations on · 6 of its ownK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  7. Descendant · 3 generations on · 5 of its ownK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  8. Descendant · 3 generations on · 4 of its ownK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  9. Descendant · 3 generations on · 3 of its ownK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 22011: 32012: 12015: 12017: 12019: 1
2009high 3 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009 · cites it directly7descendants
  • K111462Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on6descendants
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 3 generations on5descendants
  • K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 3 generations on4descendants
  • K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc.19949
−2K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp.20027
−1K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.2006—
0 (this device)K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.2006—
+1K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.2009—
+2K111462Fixate Tissue BandAnulex Technologies, Inc.2011—
+3K112849Fixate Tissue BandAnulex Technologies, Inc.2011—
+3K113400Fixate Tissue BandAnulex Technologies, Inc.2011—
+3K113805Fixate Tissue BandAnulex Technologies, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201130
201210
201510
201710
201910
FIG. 1 — Lineage of K062307, 1994–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K061386Anchor Band Suturing System, Model SR-AB
Summary page 1
…uct Classification 21 CFR §878.5000 and Code: Class: II Product Code: GAT Predicate Device: K061386 - Anulex Anchor Band Suturing System Device Description: The XcloseTM Tissue Repair System consists of two (2) non-…
Anulex Technologies, Inc.2006—

Also cleared against K061386: 1 other device →

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.20097
K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090

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 4.0 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K091432 (Anulex Technologies, Inc., 2009) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K061386.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

The XcloseTM Tissue Repair 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.

Also cleared against K061386

1 other device cites the same predicate.

  • K100572Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010

More from Anulex Technologies, Inc.

12 FDA decisions under this applicant name. See the company

  • K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc. · 2012
  • K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc. · 2012
  • K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012
  • K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K062307 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062307: Xclose Tissue Repair System, Model SRS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062307

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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