FDA 510(k) Clearances & Premarket Approvals Regulatory Clearances

• professional

Real-time notifications of newly cleared 510(k) premarket notifications, Premarket Approvals (PMA), De Novo classifications, and summary safety/predicate data for orthopaedic devices. Attendings & Fellows: Early visibility into newly commercialized joint implants, 3D-printed porous cages, bioabsorbable anchors, and hospital Value Analysis Committee (VAC) evaluations.

• 510(k) No: K253065 - Decision: Substantially Equivalent

  Device: Aevumed SUPERCYNCH™ Button System - Applicant: Aevumed, Inc.

• 510(k) No: K261311 - Decision: Substantially Equivalent

  Device: HYALOMATRIX - Applicant: Anika Therapeutics, Inc.

• 510(k) No: K262809 - Decision: Substantially Equivalent

  Device: ArthroTAK Tendon Anchor Kit - Applicant: ArthroTAK, LLC

• 510(k) No: K261749 - Decision: Substantially Equivalent

  Device: Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Applicant: Cardinalhealth

• 510(k) No: K262364 - Decision: Substantially Equivalent

  Device: Ellian Enigma RF Device - Applicant: Ellian Corp

• 510(k) No: K254026 - Decision: Substantially Equivalent

  Device: 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) - Applicant: Flexicare Medical Limited.

• 510(k) No: K261313 - Decision: Substantially Equivalent

  Device: Vivid Explorer/Vivid Advanced/Vivid Focus - Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics

• 510(k) No: K254090 - Decision: Substantially Equivalent

  Device: I-View® - Applicant: Hologic, Inc.

• 510(k) No: K262153 - Decision: Substantially Equivalent

  Device: Pivot Insulin Delivery System - Applicant: Modular Medical, Inc.

• 510(k) No: K262420 - Decision: Substantially Equivalent

  Device: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) - Applicant: Serpex Medical