# K091016: Covidien Sports Surgery as Meniscal Repair Device with High Strength Suture

- Pathway: 510(k) (Special)
- Applicant: Surgical Devices, A Global Business Unit Covidien
- Decided: May 4, 2009 after 25 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 its predicate without a number.
- (no number) Covidien Sport Surgery AS Meniscal Repair Device: named in the summary without a submission number

## Indications for use
The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries

Source page: https://510kreport.com/device/K091016
Methodology: https://510kreport.com/methodology