K150776 is an FDA 510(k) clearance for the Medrobotics Flex System. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.
Submitted by Medrobotics Corporation (Raynham, US). The FDA issued a Cleared decision on July 17, 2015 after a review of 115 days - within the typical 510(k) review window.
This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.
NCT02262247
Completed
Observational
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures
A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures
| Condition studied |
OSA; Oral Disease; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms |
| Eligibility |
All sexes
· 22 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Michael D Tricoli, BS, MBA |
| Sponsor |
Medrobotics Corporation
|
Started 2014-07-01
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Primary completion 2015-12-01
Primary outcome
Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
Study completed - no results published.
This trial concluded in 2015 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov