# K212603: Non Absorbable Surgical Nylon Suture

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Haidike Medical Product Co., Ltd.
- Decided: Dec 22, 2021 after 127 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: 4 generations back to K954808 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture, Aesculap, Inc. (2016) Summary page 5.

## Indications for use
Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.

Source page: https://510kreport.com/device/K212603
Methodology: https://510kreport.com/methodology