510(k) · Cleared

Recalled · Class II · 2014

Cottony II, Silky II Polydek & Tevdek II Polyester Suture

K021019510(k) TraditionalCleared Jun 18, 200281-day reviewClass II21 CFR 878.5000Recalls 7

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

Genzyme Corp. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jun 18, 2002 as substantially equivalent to K930738 (Deknatel, Inc., 1994) after an 81-day review. Its family tree reaches back 1 generation to 1994. 49 later devices descend from it. It has been recalled 7 times.

Decided: Jun 18, 2002
Review: 81 days
Class: Class II
Product code: GAT
Recalls: 7
Predicates: 1

Its longest line of descent runs back 1 generation to K930738 (1994). 49 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 1 generation backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
This deviceK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002
Descendant · cites it directly · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
Descendant · cites it directly · 11 of its ownK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
Descendant · 2 generations on · 9 of its ownK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
Descendant · 2 generations on · 7 of its ownK153307 HS SutureTapeRiverpoint Medical · 2016
Descendant · 2 generations on · 7 of its ownK100572 Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2003high 7 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 49 · See all

K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · cites it directly15descendants
K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006 · cites it directly11descendants
K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006 · 2 generations on9descendants
K153307HS SutureTapeRiverpoint Medical · 2016 · 2 generations on7descendants
K100572Versaclose, Model VC-200-01Anulex Technologies, Inc. · 2010 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930738	Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc	Deknatel, Inc.	1994	9
0 (this device)	K021019	Cottony II, Silky II Polydek & Tevdek II Polyester Suture	Genzyme Corp.	2002	—
+1	K100006	HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)…	Riverpoint Medical	2010	2
+1	K061386	Anchor Band Suturing System, Model SR-AB	Anulex Technologies, Inc.	2006	—
+2	K062307	Xclose Tissue Repair System, Model SRS	Anulex Technologies, Inc.	2006	—
+2	K153307	HS SutureTape	Riverpoint Medical	2016	—
+2	K100572	Versaclose, Model VC-200-01	Anulex Technologies, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	3	0
2008	1	0
2009	4	0
2010	7	0
2011	5	0
2012	2	0
2015	5	0
2016	4	0
2017	1	0
2018	1	0
2019	2	0
2020	4	0
2021	1	0
2023	1	0
2024	3	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K021019, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K930738	Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc Summary page 2 …nce The device is similar in intended use, materials, design, and performance characteristics to the currently cleared Polyester Nonabsorbable Surgical Sutures (#K930738). The determination of substantial equivalence for this device was based on a detailed device description, performance tes…	Deknatel, Inc.	1994	9

Also cleared against K930738: 8 other devices →

What descends from it? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K100006	HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…	Riverpoint Medical	2010	15
K061386	Anchor Band Suturing System, Model SR-AB	Anulex Technologies, Inc.	2006	11
K061276	G-Prox Endoscopic Grasper	Usgi Medical	2006	5
K153076	silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…	Teleflexmedical, Inc.	2016	4
K153089	'cottony' II TAPE, PLEDGETS	Teleflexmedical, Inc.	2016	2
K112683	Smi Cardiovascular Pach	Solimas Medical, Inc.	2011	1
K101252	Neotract Anchor System Model: Ref 11208	Neotract, Inc.	2010	1
K091061	Implicitguide Surgical Suture System	Implicitcare, LLC	2009	1
K032901	Stryker Mini-Mender Meniscal Repair System	Stryker Endoscopy	2003	1
K230510	MyEllevate	Cynosure, LLC	2023	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 11, 2014	Class II	Z-1291-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Mar 11, 2014	Class II	Z-1294-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Mar 11, 2014	Class II	Z-1295-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Mar 11, 2014	Class II	Z-1296-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Mar 11, 2014	Class II	Z-1292-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Mar 11, 2014	Class II	Z-1293-2014	Employee error	The products are being recalled because they did not meet minimum needle attachment strength requirements.
Jun 6, 2007	Not classified	Z-1017-2007	Other	Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K100006 (Riverpoint Medical, 2010) has gone furthest, with 15 descendants of its own.
8 other devices also cite its predicate K930738.

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

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

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

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

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021019

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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