CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE— 510(k) K862481

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K862481 for CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE, Substantially Equivalent on 1986-07-23. Applicant: CIVCO Medical Instruments Co., Inc..

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1986-06-30
Decision date: 1986-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, US

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.