BIOPSY SITE TISSUE MARKER DEVICE— 510(k) K023450

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K023450 for BIOPSY SITE TISSUE MARKER DEVICE, Substantially Equivalent on 2002-12-19. Applicant: Promex, Inc..

Clearance details

Applicant: Promex, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2002-10-15
Decision date: 2002-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, IN, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.