510(k) K213171

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) by Meditrina, Inc. — Product Code HIH

K213171 is an FDA 510(k) premarket notification submitted by Meditrina, Inc. for the device "Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Meditrina, Inc. has at least 4 other 510(k) clearances on record.