510(k) K072814

CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES by Covidien — Product Code KDD

K072814 is an FDA 510(k) premarket notification submitted by Covidien for the device "CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES". The FDA issued a decision of Substantially Equivalent on April 16, 2008. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Covidien has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2008
Date Received
October 1, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type