# K021767: Assufil

- Pathway: 510(k) (Traditional)
- Applicant: Assut Europe S.P.A.
- Decided: Nov 19, 2002 after 174 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Assufil™ It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation

Source page: https://510kreport.com/device/K021767
Methodology: https://510kreport.com/methodology