BIOPSY NEEDLE GUIDE KIT, STERILE— 510(k) K871503

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K871503 for BIOPSY NEEDLE GUIDE KIT, STERILE, Substantially Equivalent on 1987-07-10. Applicant: Amedic USA.

Clearance details

Applicant: Amedic USA
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1987-04-17
Decision date: 1987-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.