Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease. “The ability to obtain an accurate and real-time measurement from inside a diseased vessel is […]
510(k)
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
FDA denies Milestone Scientific’s Compu-Flo 510(k) application
Milestone Scientific‘s (OTC:MLSS) said today that the FDA denied the 510(k) application for its Compu-Flo intra-articular computer controlled injection system due to inadequate documentation showing that the device met required equivalency standards. The Livingston, N.J.-based company said that after meeting with the FDA’s Office of Device Evaluation, it plans to provide additional data, including a new […]
Clarius wins FDA 510(k) for wireless ultrasound device
Mobile ultrasound developer Clarius Mobile Health said today it won FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners. Clarius’ C3 multipurpose ultrasound scanner is designed to image the abdomen and lungs, with an incorporated virtual phased array for heart scans, while the L7 is designed for guiding procedures and imaging superficial […]
Lumendi wins FDA 510(k) for DiLumen endoscope positioning accessory
Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory. The Connecticut-based company’s DiLumen device is now indicated for use in positioning endoscopes in Treatments for IBS and assisting with optical visualization, diagnosis and endoscopic treatment. This most often occurs when the colon can’t pass or move stools through […]
FDA releases November 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD November 2016 TOTAL 510(k)s THIS PERIOD 254 TOTAL WITH SUMMARIES 241 TOTAL WITH STATEMENTS 13 DEVICE: Quest Diagnostics HairCheck-DT (Cocaine) Quest Diagnostics Incorporated 510(k) NO: K152232(Traditional) ATTN: Lisa Christo PHONE NO : 913 5771784 10101 Renner Blvd. SE DECISION MADE: 18-NOV-16 Lenexa KS […]
One Drop wins FDA nod, CE Mark for mobile blood glucose monitor
One Drop said today that it won 510(k) clearance from the FDA and CE Mark clearance for its One Drop | Chrome blood glucose monitoring system. The system is a part of One Drop | Premium, which the company touts as the 1st-ever monthly subscription service for affordable diabetes care. The subscription service includes unlimited blood glucose testing […]
FDA releases October 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2016 TOTAL 510(k)s THIS PERIOD 235 TOTAL WITH SUMMARIES 223 TOTAL WITH STATEMENTS 12 DEVICE: EasyMap MAP Catheter MedFact Engineering GmbH 510(k) NO: K151139(Traditional) ATTN: Joerg Reinhardt PHONE NO : 49 7621 579820 Hammerstr.3 SE DECISION MADE: 18-OCT-16 Loerrach, Baden-Wurttemberg DE D-510(k) […]
FDA clears Kyocera Medical’s Initia hip implant
Implantable medical systems maker Kyocera Medical said today it won FDA 510(k) clearance for its Initia total hip implant system. The Japanese company’s Initia total hip system includes Bioceram Azul zirconia-toughened alumina ceramic femoral heads, or can be requested with cobalt chrome femoral heads. The system includes a total 16 tapered-wedge stem sizes, with 12 […]
FDA clears BrightWater Medical’s ConvertX nephroureteral stent
Ureteral medical device company BrightWater Medical said today it won FDA 510(k) clearance for its ConvertX nephroureteral stent system designed for treating ureteral obstructions. The ConvertX System is designed as a single device intended to replace a series of devices and procedures used to treat severe obstructions of the ureter. Traditional interventions require an implanted nephrostomy catheter […]
SuperSonic Imagine wins expanded FDA nod for Aixplorer platform
SuperSonic Imagine said today it won expanded FDA 510(k) clearance for its Aixplorer platform, including clearance for additional probes and multiple new imaging modes. The new clearance includes the French company’s Angio PL.U.S PlaneWave imaging, TriVu imaging, fusion and navigation imaging, contrast liver imaging and B-Mode ratio imaging. The newly cleared Angio PL.U.S. and contrast […]