510(k) · Cleared
ClearedTevdek II, Silky II Polydek, 'Cottony' II, NextStitch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Mar 30, 2020 as substantially equivalent to K153076 (Teleflexmedical, Inc., 2016) and 2 other predicates after a 201-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Mar 30, 2020
- Review
- 201 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930738 (1994). 7 ancestors in all, the oldest K802093 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 2 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- 1 generation backK153076 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II…Teleflexmedical, Inc. · 2016
- This deviceK192490 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical · 2020
- Descendant · cites it directly · 0 of its ownK241111 AMT Suture PasserApplied Medical Technology, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241111AMT Suture PasserApplied Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −2 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| −1 | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX… | Teleflexmedical, Inc. | 2016 | — |
| 0 (this device) | K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Teleflex Medical | 2020 | — |
| +1 | K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Summary page 7…erile Tevdek® II polyester suture available in USP Size 2. F. Indications for Use and Contraindications Sterile Deknatel® Polyester Suture, previously cleared under K153076 and K153089, carries the following indications and contraindications: “silky” II POLYDEK®, ‘cottony’ II, TEVDEK® II Polye… | 2016 |
| * | K153089 | 'cottony' II TAPE, PLEDGETSSummary page 7…® II polyester suture available in USP Size 2. F. Indications for Use and Contraindications Sterile Deknatel® Polyester Suture, previously cleared under K153076 and K153089, carries the following indications and contraindications: “silky” II POLYDEK®, ‘cottony’ II, TEVDEK® II Polyester Surgica… | 2016 |
| * | K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkSummary page 8…on in cardiovascular valve replacement procedures. Contraindications: None known. Non-sterile Deknatel® Polyester Suture, previously cleared under K930739, carries the following indications and contraindications: READI-CUT TEVDEK® II Non-Sterile Polyester Surgical Suture… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241111 | AMT Suture Passer | 2024 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K241111 (Applied Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K153076.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
Polyester Surgical Suture Tapes are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
TEVDEK® II NextStitch® and ‘silky’ II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192490
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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