The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Asc Quadport + Laparoscopic Access Device.
| Device ID | K121309 |
| 510k Number | K121309 |
| Device Name: | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530440103 | K121309 | 000 |