510(k) Report

Devices descending from K041711

9 later devices reach Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…Applied Medical Resources Corporation20261—
+1K140064Surgisleeve Wound ProtectorCovidien20141—
+1K120061Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H20122—
+1K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+1K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+1K093296Alexis Laparoscopic SystemApplied Medical Resources Corp.20090—
+2K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…Applied Medical Resources Corporation20260—
+2K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+2K143091Surgisleeve Wound ProtectorCovidien, LLC20140—