# K100780: Vital Sutures, Suturex, Cirugia Peruana

- Pathway: 510(k) (Traditional)
- Applicant: Unilene Sac
- Decided: Dec 14, 2010 after 270 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- 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
The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. The absorbable sutures (Potyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K100780
Methodology: https://510kreport.com/methodology