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 |