The following data is part of a premarket notification filed by Meditrina, Inc. with the FDA for Aveta System, Aveta Disposable Hysteroscope (pearl/opal/coral), Aveta Disposable Cystoscope (coral).
| Device ID | K213171 |
| 510k Number | K213171 |
| Device Name: | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 |
| Contact | Csaba Truckai |
| Correspondent | Csaba Truckai Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 |
| Product Code | HIH |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | HIG |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2022-05-26 |