510(k) Report

Devices descending from K013870

14 later devices reach Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180496TruClear Elite HysteroscopeCovidien20180—
+1K112134Truclear Operative HysteroscopeSmith & Nephew, Inc.20117—
+1K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc.20094—
+1K081070Interlace Medical Operative Hysteroscopy SystemInterlace Medical, Inc.20080—
+2K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.20181—
+2K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc.20156—
+2K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc.20122—
+2K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc.20100—
+3K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc.20190—
+3K190372Aveta SystemMeditrina, Inc.20194—
+4K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+4K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+4K191958Aveta SystemMeditrina, Inc.20190—
+5K223813Aveta System 2.0Meditrina, Inc.20230—