The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Asc Triport Laparoscopic Access Device Model Tprt-02-01 (wa58000t), Asc Quadport Laparoscopic Asscess Device Qprt-01 (wa.
| Device ID | K101794 |
| 510k Number | K101794 |
| Device Name: | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2010-11-29 |
| Summary: | summary |