# K193530: Deklene MAXX

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Mar 19, 2020 after 90 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 4.
- K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL, Teleflexmedical, Inc. (2016) Summary page 4.

## Indications for use
Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.

Source page: https://510kreport.com/device/K193530
Methodology: https://510kreport.com/methodology