# K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Mar 30, 2020 after 201 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: 3 generations back to K930738 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL, Teleflexmedical, Inc. (2016) Summary page 7.
- K153089: 'cottony' II TAPE, PLEDGETS, Teleflexmedical, Inc. (2016) Summary page 7.
- K930739: Sutures Polyprop., Polyetheline, Nylon & Silk, Deknatel, Inc. (1994) Summary page 8.

## Most influential descendants
- K241111: AMT Suture Passer (2024), 0 descendants of its own

## 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. 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.

Source page: https://510kreport.com/device/K192490
Methodology: https://510kreport.com/methodology