# K233355: Cypris eXact Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: Cypris Medical
- Decided: Jan 12, 2024 after 105 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- 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: 12 generations back to K014153 (2002). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131224: Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure, Surgical Specialties Corp. Dba Angiotech (2013) Summary page 6.
- K160744: LOOK PTFE Suture, Surgical Specialties Corporation (2016) Summary page 6.
- K063680: Sharpoint Pdo (Polydioxanone) Sutures, Surgical Specialties Corp (2007) Summary page 6.

## Indications for use
Cypris eXact Suture PP (Polypropylene) The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Cypris eXact Suture PTFE (Polytetraflouroethylene) The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. Cypris eXact Suture PDO (Polydioxanone) The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K233355
Methodology: https://510kreport.com/methodology