Clearance Summary
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC received FDA 510(k) clearance under submission number K131072, sponsored by Coloplast A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-07-09.
- Submission: K131072
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2013-07-09
Classification & Regulation
This clearance is catalogued under FDA product code OCY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.