510(k) Report

Devices descending from K895614

25 later devices reach Civco Latex Ultrasound Sheaths through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974301CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc.19980—
+1K970891Drape, Surgical-LatexProtek Medical Products, Inc.19970—
+1K970515General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc.199721—
+1K961029Kiltex Probe CoverKiltex Corp.199612
+2K163502iSR'obot Biopsy KitBiobot Surgical Pte., Ltd.20172—
+2K991236General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…CIVCO Medical Instruments Co., Inc.199916—
+2K981406Cervix Coil Latex SheathPhilips Medical Systems (Cleveland), Inc.19980—
+3K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+3K091828Sheathesiso Ultrasound Transducer CoverSheathing Technologies, Inc.20090—
+3K050320Freescan Latex-Free Ultrasound Transducer Cover KitAscendia Medtech AB20050—
+3K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.2001143
+4K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+4K131528Non-Pyrogenic Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.20131—
+4K041077Imalux Oct Probe GuideImalux Corporation200410—
+5K222460Intraoperative Ultrasound Probe CoverExact Medical Manufacturing20230—
+5K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+6K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+6K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+6K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+7K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+8K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+9K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc.20190—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—