The following data is part of a premarket notification filed by Medtronic Navigation Inc. with the FDA for Stealthstation Flexent (9736242), Stealthstation S8 Ent Software (9735762).
| Device ID | K200723 |
| 510k Number | K200723 |
| Device Name: | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Carey Brenner |
| Correspondent | Carey Brenner Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-19 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000368494 | K200723 | 000 |
| 00763000376215 | K200723 | 000 |
| 00763000314057 | K200723 | 000 |
| 00763000314002 | K200723 | 000 |
| 00763000312602 | K200723 | 000 |
| 00763000336592 | K200723 | 000 |
| 00763000312572 | K200723 | 000 |
| 00763000456993 | K200723 | 000 |