510(k) Report

Devices descending from K971165

11 later devices reach Introducer Sheath and Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020563Medamicus Axia RSNMedamicus, Inc.20023—
+1K981611Snap-N-Peel IntroducersCircon Corp.19986—
+2K123170Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America20131—
+2K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation200552
+2K040029Safetynet Guidewire IntroducerInjectimed, Inc.20041—
+2K022689Modification to Medamicus Axia RSNMedamicus, Inc.20022—
+3K182403Peel-Away IntroducerCook Incorporated20190—
+3K120160Rocamed Rocaus PlatinumPromepla Sam20122—
+3K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.20080—
+4K140441BI-Flex Ureteral Access SheathPromepla Sam20141—
+5K182144Bi-Flex EvoPromepla Sam20180—