Cleared Traditional

CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES

K072814 · Covidien · General & Plastic Surgery
Apr 2008
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K072814 is an FDA 510(k) clearance for the CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on April 16, 2008, 198 days after receiving the submission on October 1, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K072814 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2007
Decision Date April 16, 2008
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KDD — Kit, Surgical Instrument, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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