# K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 18, 2002 after 81 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930738 (1994). 1 ancestor in all.
49 later devices descend from it; 12 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994) Summary page 2.

## Most influential descendants
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), 15 descendants of its own
- K061386: Anchor Band Suturing System, Model SR-AB (2006), 11 descendants of its own
- K062307: Xclose Tissue Repair System, Model SRS (2006), 9 descendants of its own
- K153307: HS SutureTape (2016), 7 descendants of its own
- K100572: Versaclose, Model VC-200-01 (2010), 7 descendants of its own

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1291-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Mar 11, 2014 · Class II · Z-1294-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Mar 11, 2014 · Class II · Z-1295-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Mar 11, 2014 · Class II · Z-1296-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Mar 11, 2014 · Class II · Z-1292-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Mar 11, 2014 · Class II · Z-1293-2014: The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Jun 6, 2007 · Not classified · Z-1017-2007: 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.

## Indications for use
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

Source page: https://510kreport.com/device/K021019
Methodology: https://510kreport.com/methodology