K930483 is the FDA 510(k) clearance record for URETERAL CATHETER, a class II device, cleared for Surgitek on 1993-07-16 under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 29 510(k) clearances for Surgitek, from 1983-10-14 to 1995-03-06 . As of 2026-09-10 , FDA records show no recalls naming K930483.
Clearance record Decision date 1993-07-16 Received 1993-01-29 (168 days to decision) Product code EYB Catheter, Ureteral, Gastro-UrologyRegulation 21 CFR 876.5130 Device class Class II Review panel Gastroenterology, Urology Applicant Surgitek 3037 Mt. Pleasant St., Racine WI 510(k) summary Statement Third party review No
Clearances, product code EYB Trailing 12 months FDA records hold no clearances under product code EYB in the trailing twelve months.
FDA records show no clearances under product code EYB in the twelve months to October 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 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
