The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Acclarent Cyclops Multi-angle Endoscope.
| Device ID | K100577 |
| 510k Number | K100577 |
| Device Name: | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Keri Yen |
| Correspondent | Keri Yen ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-01 |
| Decision Date | 2011-01-06 |
| Summary: | summary |