The following data is part of a premarket notification filed by Coviden (formerly Registered As Us Surgical, A Div with the FDA for Sils Port.
| Device ID | K103253 |
| 510k Number | K103253 |
| Device Name: | SILS PORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDEN (FORMERLY REGISTERED AS US SURGICAL, A DIV 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Tim M Lohnes |
| Correspondent | Tim M Lohnes COVIDEN (FORMERLY REGISTERED AS US SURGICAL, A DIV 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521102788 | K103253 | 000 |
| 20884521102771 | K103253 | 000 |
| 20884521102764 | K103253 | 000 |