STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510— 510(k) K921613

Substantially Equivalent

Dept. of the Army

FDA 510(k) clearance K921613 for STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510, Substantially Equivalent on 1993-01-29. Applicant: Dept. of the Army.

Clearance details

Applicant: Dept. of the Army
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1992-04-06
Decision date: 1993-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Falls Church, VA, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.