Cleared Special

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA

K101794 · Advanced Surgical Concepts · General & Plastic Surgery
Nov 2010
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K101794 is an FDA 510(k) clearance for the ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA, a Laparoscopic Single Port Access Device (Class II — Special Controls, product code OTJ), submitted by Advanced Surgical Concepts (North Attleboro, US). The FDA issued a Cleared decision on November 29, 2010, 154 days after receiving the submission on June 28, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K101794 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2010
Decision Date November 29, 2010
Days to Decision 154 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.