K171307 is an FDA 510(k) clearance for the EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Devic.... Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.
Submitted by Endogastric Solutions, Inc. (Redmond, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 50 days - a notably fast clearance cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.
View all Endogastric Solutions, Inc. devices
NCT01327963
Terminated
Interventional
Industry-sponsored
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
| Condition studied |
Gastroesophageal Reflux Disease (GERD) |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
William Barnes, MD MBA FACS |
| Sponsor |
EndoGastric Solutions
(industry)
|
Started 2010-09-01
→
Primary completion 2014-02-01
Primary outcome
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Secondary outcome
Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
View full study on ClinicalTrials.gov