Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Endogastric Solutions, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time
164 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.2024-04-26282
K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.2017-10-19310
K171307EsophyX2 HD Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.2017-06-22500
K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.2016-05-01260
K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc.2015-03-04720
K142113ESOPHYX2 HDEndogastric Solutions, Inc.2014-09-30570
K092400ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENEndogastric Solutions, Inc.2009-11-06922
K091832ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTEEndogastric Solutions, Inc.2009-07-22300
K073644ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIESEndogastric Solutions, Inc.2008-06-271840
K071651EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEEndogastric Solutions, Inc.2007-09-14880
K062875ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIESEndogastric Solutions, Inc.2007-03-091640

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda