The following data is part of a premarket notification filed by Acuvu Inc. with the FDA for Gdt-1000 System.
| Device ID | K180096 |
| 510k Number | K180096 |
| Device Name: | GDT-1000 System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | AcuVu Inc. 1749 Broadway Street Redwood City, CA 94063 |
| Contact | Sam Mostafavi |
| Correspondent | Sam Mostafavi AcuVu Inc. 1749 Broadway Street Redwood City, CA 94063 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-04-16 |
| Summary: | summary |