# K240185: Cypris eXact Suture Placement Device

- Pathway: 510(k) (Traditional)
- Applicant: Cypris Medical
- Decided: May 3, 2024 after 101 days
- Product code: GEJ (Carrier, Ligature)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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) Cypris eXact 5.1 Suture Placement Device: named in the summary without a submission number

## Indications for use
The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

Source page: https://510kreport.com/device/K240185
Methodology: https://510kreport.com/methodology