PROCEDURE KIT— 510(k) K926269

Name: FDA 510(k) clearance K926269
Creator: U.S. Food and Drug Administration
Published: 1993-08-27

Unknown

General Medical Co.

FDA 510(k) clearance K926269 for PROCEDURE KIT, Unknown on 1993-08-27. Applicant: General Medical Co.. Device class: 2.

Clearance details

Applicant: General Medical Co.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1992-12-18
Decision date: 1993-08-27
Decision: Unknown
Clearance type: Traditional
Location: Richmond, VA, 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.