The following data is part of a premarket notification filed by Covidien with the FDA for Convenience Kit For Single-incision Laparoscopic Surgery And Other Advanced Laparoscopic Procedures.
| Device ID | K072814 |
| 510k Number | K072814 |
| Device Name: | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Robert Zott |
| Correspondent | Robert Zott COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-01 |
| Decision Date | 2008-04-16 |
| Summary: | summary |