Clearance Summary
Digitex Delivery Device received FDA 510(k) clearance under submission number K173527, sponsored by Coloplast A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-02-12.
- Submission: K173527
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4910
- Decision date: 2018-02-12
Classification & Regulation
This clearance is catalogued under FDA product code PWI and 21 CFR 884.4910, within the Obstetrics/Gynecology review panel as a Class II device.