Cleared Special

ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE

K110004 · Advanced Surgical Concepts · General & Plastic Surgery
Jan 2011
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K110004 is an FDA 510(k) clearance for the ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE, a Laparoscopic Single Port Access Device (Class II — Special Controls, product code OTJ), submitted by Advanced Surgical Concepts (Washington, US). The FDA issued a Cleared decision on January 26, 2011, 23 days after receiving the submission on January 3, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K110004 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2011
Decision Date January 26, 2011
Days to Decision 23 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OTJ — Laparoscopic Single Port Access Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.