Clearance Summary
REPROCESSED TROCARS, MODEL B5LT AND CB5LT received FDA 510(k) clearance under submission number K100080, sponsored by Ascent Healthcare Solutions. 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 2010-03-19.
- Submission: K100080
- Applicant / Sponsor: Ascent Healthcare Solutions
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-03-19
Classification & Regulation
This clearance is catalogued under FDA product code NLM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.