K072814 is an FDA 510(k) clearance for the CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K072814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | KDD — Kit, Surgical Instrument, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |