FDA-Device2012-12-12Class II
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as e
OmniGuide, Inc.
Hazard
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Sold states
Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
Affected count
45 units
Manufactured in
One Kendall Square, Building 100, 3rd floor, Cambridge, MA, United States
Products
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2013Don't want to check this manually?
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