TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709— 510(k) K831392

Name: FDA 510(k) clearance K831392
Creator: U.S. Food and Drug Administration
Published: 1983-07-12

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K831392 for TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709, Substantially Equivalent on 1983-07-12. Applicant: Travenol Laboratories, S.A.. Device class: 1.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-04-29
Decision date: 1983-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.