510(k) Report

510(k) · Cleared

Cleared

Xclose Tissue Repair System, Model XC-200-01

K091432510(k) SpecialCleared Jun 12, 200929-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 Jun 12, 2009 as substantially equivalent to K062307 (Anulex Technologies, Inc., 2006) after a 29-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.

Decided
Jun 12, 2009
Review
29 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K930738 (1994). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1998: 1 other ancestor2011: 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 · recalled×2: 2 generations cleared close together, K061386 (2006), K062307 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K062307 · Xclose Tissue Repair System, Model SRS · Anulex Technologies, Inc. · 2006K061386 · 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
  1. Root · 4 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
  2. 3 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
  3. 2 generations backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
  4. 1 generation backK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
  5. This deviceK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
  6. Descendant · cites it directly · 6 of its ownK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  7. Descendant · 2 generations on · 5 of its ownK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  8. Descendant · 2 generations on · 4 of its ownK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  9. Descendant · 2 generations on · 3 of its ownK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
  10. Descendant · 3 generations on · 2 of its ownK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 32012: 12015: 12017: 12019: 1
2011high 3 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all
  • K111462Fixate Tissue BandAnulex Technologies, Inc. · 2011 · cites it directly6descendants
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on5descendants
  • K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on4descendants
  • K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012 · 2 generations on3descendants
  • K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…Anchor Innovation Medical (A.I.M.) · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc.19949
−3K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp.20027
−2K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.2006—
−1K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.2006—
0 (this device)K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.2009—
+1K111462Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K112849Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K113400Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K113805Fixate Tissue BandAnulex Technologies, Inc.2012—
+3K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter…Anchor Innovation Medical (A.I.M.)2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
201210
201510
201710
201910
FIG. 1 — Lineage of K091432, 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
*K062307Xclose Tissue Repair System, Model SRS
Summary page 1
…Repair System Product Classification 21 CFR §878.5000 and Code: Class: II Product Code: GAT Predicate Device: K062307 - Xclose Tissue Repair System Device Description: The modified XCloSeTm Tissue Repair System consists of two (2)…
Anulex Technologies, Inc.2006—

Also cleared against K062307: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111462Fixate Tissue BandAnulex Technologies, Inc.20116

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 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K111462 (Anulex Technologies, Inc., 2011) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K062307.

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. 2009, this device’s year, is highlighted.

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 Xclose TM 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 K062307

1 other device cites the same predicate.

  • K082518Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009

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/K091432 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091432: Xclose Tissue Repair System, Model XC-200-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091432

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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