510(k) Report

Devices descending from K991236

16 later devices reach General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091828Sheathesiso Ultrasound Transducer CoverSheathing Technologies, Inc.20090—
+1K050320Freescan Latex-Free Ultrasound Transducer Cover KitAscendia Medtech AB20050—
+1K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.2001143
+2K131528Non-Pyrogenic Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.20131—
+2K041077Imalux Oct Probe GuideImalux Corporation200410—
+3K222460Intraoperative Ultrasound Probe CoverExact Medical Manufacturing20230—
+3K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+4K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+4K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+4K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+5K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+6K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc.20190—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—