Clearance Summary
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX received FDA 510(k) clearance under submission number K120284, sponsored by Coloplast A/S. 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 2012-05-23.
- Submission: K120284
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4840
- Decision date: 2012-05-23
Classification & Regulation
This clearance is catalogued under FDA product code NEW and 21 CFR 878.4840, within the General, Plastic Surgery review panel as a Class II device.