510(k) · Cleared
Cleared'cottony' II TAPE, PLEDGETS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Aug 12, 2016 as substantially equivalent to K021019 (Genzyme Corp., 2002) after a 291-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 12, 2016
- Review
- 291 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930738 (1994). 2 later devices descend from it, 1 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 deviceK153089 'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192490 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical · 2020
- Descendant · 2 generations on · 0 of its ownK241111 AMT Suture PasserApplied Medical Technology, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K153089 | 'cottony' II TAPE, PLEDGETS | Teleflexmedical, Inc. | 2016 | — |
| +1 | K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Teleflex Medical | 2020 | — |
| +2 | K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 9…“silky” II POLYDEK® & June 18, TEVDEK® II Polyester Nonabsorbable Genzyme Corp K021019 2002 Surgical Suture… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | 2020 | 1 |
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 22 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K192490 (Teleflex Medical, 2020) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K021019.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
'cottony'™ II Polyester Suture Tape is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153089: 'cottony' II TAPE, PLEDGETS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153089
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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