The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Apollo System.
| Device ID | K152699 |
| 510k Number | K152699 |
| Device Name: | Apollo System |
| Classification | Endoscope, Neurological |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Mary Rose |
| Correspondent | Mary Rose PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-03-17 |
| Summary: | summary |