The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell.
| Device ID | K141456 |
| 510k Number | K141456 |
| Device Name: | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | FIAGON GMBH NEUENDORFSTRASSE 23B Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha FIAGON GMBH NEUENDORFSTRASSE 23B Hennigsdorf, DE 16761 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0129111 | K141456 | 000 |
| EFIAE0121041 | K141456 | 000 |
| EFIAE0121061 | K141456 | 000 |
| EFIAE0129001 | K141456 | 000 |
| EFIAE0129011 | K141456 | 000 |
| EFIAE0129021 | K141456 | 000 |
| EFIAE0121011 | K141456 | 000 |
| EFIAE0121021 | K141456 | 000 |
| EFIAE0121031 | K141456 | 000 |
| EFIAE0129101 | K141456 | 000 |
| EFIAE0120031 | K141456 | 000 |