Clearance Summary
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA received FDA 510(k) clearance under submission number K101794, sponsored by Advanced Surgical Concepts. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-11-29.
- Submission: K101794
- Applicant / Sponsor: Advanced Surgical Concepts
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-11-29
Classification & Regulation
This clearance is catalogued under FDA product code OTJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.