510(k) Report

510(k) · Cleared

Cleared

Dual Needle Suture Passer System

K082518510(k) TraditionalCleared Jan 16, 2009136-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

Cayenne Medical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jan 16, 2009 as substantially equivalent to K063778 (Teleflex Medical, 2007) and 4 other predicates after a 136-day review. Its family tree reaches back 4 generations to 1999.

Decided
Jan 16, 2009
Review
136 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K990088 (1999). 29 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 2 other ancestors2002: 3 other ancestors2005: 1 other ancestor2004: 3 other ancestors2001: 4 other ancestors2000: 4 other ancestors1998: 2 other ancestors1996: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestorK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K041894 · Orthofiber · Cp Medical · 200419901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors3 generations back: 10 other ancestors4 generations back: 1 other ancestor K041894 · Orthofiber · Cp Medical · 2004K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990
  1. Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 1 generation backK041894 OrthofiberCp Medical · 2004
  5. This deviceK082518 Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−3K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−2K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−1K041894OrthofiberCp Medical2004—
0 (this device)K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199420
199610
199820
200040
200140
200230
200430
200510
200620
200720
FIG. 1 — Lineage of K082518, 1999–2009Source: 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? (5)

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
*K063778Force Fiber Polyethylene Nonabsorbable Suture
Summary page 2
…determined by FDA to be substantially equivalent to pieamendment devices Teleflex Medical's Foice FiberTM, Non-absorbable Polyethylene Surgical Suture (K063778), CP Medical's CP Fiber Non-absorbable Polyblended Surgical Suture (K041894), DePuy Mitek's (Mitek Worldwide) R…
Teleflex Medical20071
*K041894Orthofiber
Summary page 2
…eflex Medical's Foice FiberTM, Non-absorbable Polyethylene Surgical Suture (K063778), CP Medical's CP Fiber Non-absorbable Polyblended Surgical Suture (K041894), DePuy Mitek's (Mitek Worldwide) RAPIDLOC-PDS Mensical Repair System (K023388), Aniilex…
Cp Medical2004—
*K023388Mitek Rapidloc-PDS Meniscal Repair System
Summary page 2
…3778), CP Medical's CP Fiber Non-absorbable Polyblended Surgical Suture (K041894), DePuy Mitek's (Mitek Worldwide) RAPIDLOC-PDS Mensical Repair System (K023388), Aniilex m Teclmologies's XcloseTh Tissue Repair System (K062307), and Suith & Nephew…
Mitek Worldwide2002—
*K062307Xclose Tissue Repair System, Model SRS
Summary page 2
…(Mitek Worldwide) RAPIDLOC-PDS Mensical Repair System (K023388), Aniilex m Teclmologies's XcloseTh Tissue Repair System (K062307), and Suith & Nephew s ULTRA FAST-FIX Mentscal Repair System (K072322)…
Anulex Technologies, Inc.2006—
*K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems
Summary page 2
…m Teclmologies's XcloseTh Tissue Repair System (K062307), and Suith & Nephew s ULTRA FAST-FIX Mentscal Repair System (K072322) pi- mgP 12…
Smith & Nephew, Inc.2007—

Also cleared against K063778: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 10 of the 29 ancestors have a recall of any class.
  • 16 other devices also cite its predicate K063778.

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 Dual Needle Suture Passei System is intended for approximation of soft tissue m procedures such as memscal repair

Indications for use as stated in the FDA summary.

Also cleared against K063778

16 other devices cite the same predicate.

  • K191268Force Fiber SutureTeleflex Medical Incorporated · 2019
  • K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture…Teleflex Medical Incorporated · 2018
  • K172016Force Fiber Fusion SutureTeleflex Medical Incorporated · 2017
  • K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc · 2017
  • K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc. · 2015
  • K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC · 2015

More from Cayenne Medical, Inc.

22 FDA decisions under this applicant name. See the company

  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017
  • K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015
  • K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock…Cayenne Medical, Inc. · 2015

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/K082518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082518: Dual Needle Suture Passer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082518

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