The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Flexible Video-neuro-endoscope System.
| Device ID | K161112 |
| 510k Number | K161112 |
| Device Name: | KARL STORZ Flexible Video-Neuro-Endoscope System |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Contact | Susie S. Chen |
| Correspondent | Nozomi Yagi KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-20 |
| Decision Date | 2016-09-17 |
| Summary: | summary |