510(k) Report

Devices descending from K152143

6 later devices reach TRUCLEAR Operative Hysteroscope 5C and Sheath 5C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190372Aveta SystemMeditrina, Inc.20194—
+1K180496TruClear Elite HysteroscopeCovidien20180—
+2K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+2K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+2K191958Aveta SystemMeditrina, Inc.20190—
+3K223813Aveta System 2.0Meditrina, Inc.20230—