The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Karl Storz Nav1 Electromagnetic Navigation System.
| Device ID | K161555 |
| 510k Number | K161555 |
| Device Name: | KARL STORZ NAV1 Electromagnetic Navigation System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551346594 | K161555 | 000 |
| 04048551346587 | K161555 | 000 |
| 04048551387368 | K161555 | 000 |
| 04048551387344 | K161555 | 000 |
| 04048551337820 | K161555 | 000 |
| 04048551337707 | K161555 | 000 |
| 04048551336854 | K161555 | 000 |