510(k) Report

Devices descending from K971188

15 later devices reach Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013870Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow…Smith & Nephew, Inc.200214—
+2K180496TruClear Elite HysteroscopeCovidien20180—
+2K112134Truclear Operative HysteroscopeSmith & Nephew, Inc.20117—
+2K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc.20094—
+2K081070Interlace Medical Operative Hysteroscopy SystemInterlace Medical, Inc.20080—
+3K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.20181—
+3K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc.20156—
+3K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc.20122—
+3K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc.20100—
+4K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc.20190—
+4K190372Aveta SystemMeditrina, Inc.20194—
+5K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+5K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+5K191958Aveta SystemMeditrina, Inc.20190—
+6K223813Aveta System 2.0Meditrina, Inc.20230—