The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Apollo System.
| Device ID | K132931 |
| 510k Number | K132931 |
| Device Name: | APOLLO SYSTEM |
| Classification | Endoscope, Neurological |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Seth Schulman |
| Correspondent | Seth Schulman PENUMBRA, INC. 1351 HARBOR BAY PARKWAY 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 | 2013-09-18 |
| Decision Date | 2014-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017563 | K132931 | 000 |
| 00814548012711 | K132931 | 000 |
| 00814548012728 | K132931 | 000 |
| 00814548013589 | K132931 | 000 |
| 00814548013596 | K132931 | 000 |
| 00814548013602 | K132931 | 000 |
| 00814548013619 | K132931 | 000 |
| 00814548016344 | K132931 | 000 |
| 00814548016351 | K132931 | 000 |
| 00814548016368 | K132931 | 000 |
| 00814548016375 | K132931 | 000 |
| 00814548016382 | K132931 | 000 |
| 00814548016474 | K132931 | 000 |
| 00814548012704 | K132931 | 000 |