DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT— 510(k) K945831

Name: FDA 510(k) clearance K945831
Creator: U.S. Food and Drug Administration
Published: 1995-01-20

Substantially Equivalent

Micromed Development Corp.

FDA 510(k) clearance K945831 for DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT, Substantially Equivalent on 1995-01-20. Applicant: Micromed Development Corp.. Device class: 2.

Clearance details

Applicant: Micromed Development Corp.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-11-29
Decision date: 1995-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.