K963044 is the FDA 510(k) clearance record for ENDOBEAM, a class II device, cleared for Corin USA on 1996-09-20 under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 78 510(k) clearances for Corin USA, from 1996-09-20 to 2025-06-05 . As of 2026-09-10 , FDA records show no recalls naming K963044.
Clearance record Decision date 1996-09-20 Received 1996-08-05 (46 days to decision) Product code GCT Light Source, Endoscope, Xenon ArcRegulation 21 CFR 876.1500 Device class Class II Review panel Gastroenterology, Urology Applicant Corin USA 10500 University Center Dr., Tampa FL 510(k) summary Summary Third party review No
Clearances, product code GCT Trailing 12 months FDA records hold no clearances under product code GCT in the trailing twelve months.
FDA records show no clearances under product code GCT in the twelve months to November 2026. Show the numbers FIRST ARTICLE / WEEKLY
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About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-10-26 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
