# K060465: Premio

- Pathway: 510(k) (Traditional)
- Applicant: Peters Surgical
- Decided: Jan 17, 2007 after 329 days
- Product code: MXW (Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride))
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001625 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001625: Pronova Nonabsorbable Suture, Usp, ETHICON, Inc. (2000)

## Indications for use
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery.

Source page: https://510kreport.com/device/K060465
Methodology: https://510kreport.com/methodology