# K221767: Surgical Sutures with or without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Huaian Seamen Medical Technology Co., Ltd.
- Decided: Jul 31, 2023 after 409 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- 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 K930586 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080684: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 8.

## Indications for use
Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days. Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days. Non-absorbable Polyamide Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.

Source page: https://510kreport.com/device/K221767
Methodology: https://510kreport.com/methodology