E-Z PREP(R) TRAY WITH HIBICLENS(R)— 510(k) K935483

Name: FDA 510(k) clearance K935483
Creator: U.S. Food and Drug Administration
Published: 1994-02-09

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K935483 for E-Z PREP(R) TRAY WITH HIBICLENS(R), Substantially Equivalent on 1994-02-09. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1993-11-15
Decision date: 1994-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lake, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.