SURE-FLO IRRIGATION Y TUBING SET— 510(k) K944119

Name: FDA 510(k) clearance K944119
Creator: U.S. Food and Drug Administration
Published: 1994-12-05

Substantially Equivalent

O.R. Resources, Inc.

FDA 510(k) clearance K944119 for SURE-FLO IRRIGATION Y TUBING SET, Substantially Equivalent on 1994-12-05. Applicant: O.R. Resources, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Resources, Inc.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1994-08-23
Decision date: 1994-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.