510(k) Report

Devices descending from K931417

15 later devices reach Sterile Equipment Covers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052668OR Specific Big Case Back Table CoverOr Specific, Inc.20060—
+1K050322Microtek Equipment DrapesMicrotek Medical, Inc.2005917
+1K023540Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09Valumed20031—
+1K014239Medsurg Equipment CoversInternational Medsurg Connection20021—
+1K961699Equipment CoversUnited States Surgical, A Division of Tyco Healthc19965—
+2K141438Whitney Medical Solutions EshieldWhitney Medical Solutions20140—
+2K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+2K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+2K081476Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs20081—
+2K052395Sterile Equipment CoversVolcano Corporation200512
+2K041501Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd.200406
+2K023539Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, TransflowValumed20020—
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K121436Das Medical Equipment DrapesDas Medical, LLC20130—
+3K091343Mri Neuro DrapeSurgivision, Inc.20090—