SAFETY BIOPSY NEEDLE SYSTEM— 510(k) K140137

Name: FDA 510(k) clearance K140137
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Substantially Equivalent

Pfm Medical, Inc.

FDA 510(k) clearance K140137 for SAFETY BIOPSY NEEDLE SYSTEM, Substantially Equivalent on 2014-03-25. Applicant: Pfm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2014-01-22
Decision date: 2014-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.