Cleared Special

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

K121309 · Advanced Surgical Concepts · General & Plastic Surgery

Sep 2012

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K121309 is an FDA 510(k) clearance for the ASC QUADPORT + 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 September 6, 2012, 128 days after receiving the submission on May 1, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K121309 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2012
Decision Date	September 06, 2012
Days to Decision	128 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.