Clearance Summary
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE received FDA 510(k) clearance under submission number K093112, sponsored by Coloplast Manufacturing Us, LLC. 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 2010-02-01.
- Submission: K093112
- Applicant / Sponsor: Coloplast Manufacturing Us, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5010
- Decision date: 2010-02-01
Classification & Regulation
This clearance is catalogued under FDA product code GAW and 21 CFR 878.5010, within the General, Plastic Surgery review panel as a Class II device.