# K153089: 'cottony' II TAPE, PLEDGETS

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Aug 12, 2016 after 291 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930738 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 9.

## Most influential descendants
- K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (2020), 1 descendant of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own

## Indications for use
'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.

Source page: https://510kreport.com/device/K153089
Methodology: https://510kreport.com/methodology