The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Image1 Spies System.
| Device ID | K160044 |
| 510k Number | K160044 |
| Device Name: | Image1 SPIES System |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | KARL STORZ ENDOSCOPY AMERICA, INC. 2151 E. GRAND AVE El Segundo, CA 90245 |
| Contact | Susie S. Chen |
| Correspondent | Winkie Wong KARL STORZ ENDOSCOPY AMERICA, INC. 2151 E. GRAND AVE El Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-08 |
| Decision Date | 2016-02-01 |
| Summary: | summary |