Cleared Traditional

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

K172775 · Teleflexmedical, Inc. · Gastroenterology & Urology

Feb 2018

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K172775 is an FDA 510(k) clearance for the MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle, a Endoscopic Tissue Approximation Device (Class II — Special Controls, product code OCW), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on February 12, 2018, 151 days after receiving the submission on September 14, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K172775 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2017
Decision Date	February 12, 2018
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCW — Endoscopic Tissue Approximation Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.