510(k) Report

Devices descending from K112134

7 later devices reach Truclear Operative Hysteroscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc.20156—
+2K190372Aveta SystemMeditrina, Inc.20194—
+2K180496TruClear Elite HysteroscopeCovidien20180—
+3K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+3K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+3K191958Aveta SystemMeditrina, Inc.20190—
+4K223813Aveta System 2.0Meditrina, Inc.20230—