510(k) Report

Devices descending from K970515

21 later devices reach General Purpose Latex Transducer Covers through their predicates, nearest generation first.

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