4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS— 510(k) K933109

Name: FDA 510(k) clearance K933109
Creator: U.S. Food and Drug Administration
Published: 1994-03-28

Unknown

Boston Pacific Medical, Inc.

FDA 510(k) clearance K933109 for 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS, Unknown on 1994-03-28. Applicant: Boston Pacific Medical, Inc.. Device class: 2.

Clearance details

Applicant: Boston Pacific Medical, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-25
Decision date: 1994-03-28
Decision: Unknown
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K931048 — 4-SURE NELATON CATHETER1994-02-14
K921852 — 4 SURE TM RECTAL TUBE1993-10-08
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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.