GENERAL PURPOSE KIT— 510(k) K881083

Name: FDA 510(k) clearance K881083
Creator: U.S. Food and Drug Administration
Published: 1988-04-07

Unknown

Med-Dex Intl.

FDA 510(k) clearance K881083 for GENERAL PURPOSE KIT, Unknown on 1988-04-07. Applicant: Med-Dex Intl.. Device class: 2.

Clearance details

Applicant: Med-Dex Intl.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1988-03-14
Decision date: 1988-04-07
Decision: Unknown
Clearance type: Traditional
Location: Irvine, CA, 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.