Clearance Summary
Cypris eXact Suture Placement Device received FDA 510(k) clearance under submission number K240185, sponsored by Cypris Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-05-03.
- Submission: K240185
- Applicant / Sponsor: Cypris Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2024-05-03
Classification & Regulation
This clearance is catalogued under FDA product code GEJ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.