# K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 17, 2016 after 292 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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 K954808 (1996). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990090: Dafilon Nonabsorbable Polyamide Surgical Suture, Aesculap, Inc. (1999) Summary page 4.
- K133890: Aesculap Optilene Nonabsorbable Suture, Aesculap, Inc. (2014) Summary page 4.

## Most influential descendants
- K192420: Crownjun Nylon Suture (2020), 1 descendant of its own
- K221280: Vesseal (2022), 0 descendants of its own
- K212603: Non Absorbable Surgical Nylon Suture (2021), 0 descendants of its own

## Indications for use
Dafilon Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neurological procedures.

Source page: https://510kreport.com/device/K151165
Methodology: https://510kreport.com/methodology