The following data is part of a premarket notification filed by Aegis Surgical Ltd with the FDA for Illuminated Mediastinal Access Port.
| Device ID | K160171 |
| 510k Number | K160171 |
| Device Name: | Illuminated Mediastinal Access Port |
| Classification | Mediastinoscope, Surgical |
| Applicant | Aegis Surgical Ltd 4020 Stirrup Creek Drive Suite 115 Durham, NC 27703 |
| Contact | William Starling |
| Correspondent | Robert Hefter Aegis Surgical Ltd 4020 Stirrup Creek Drive Suite 115 Durham, NC 27703 |
| Product Code | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10863189000318 | K160171 | 000 |