The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Triport, Triport+, Triport15, Quadport.
| Device ID | K111407 |
| 510k Number | K111407 |
| Device Name: | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2012-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530440097 | K111407 | 000 |