TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE— 510(k) K073399

Name: FDA 510(k) clearance K073399
Creator: U.S. Food and Drug Administration
Published: 2007-12-21

Substantially Equivalent

Envisioneering, LLC

FDA 510(k) clearance K073399 for TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE, Substantially Equivalent on 2007-12-21. Applicant: Envisioneering, LLC. Device class: 2.

Clearance details

Applicant: Envisioneering, LLC
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2007-12-04
Decision date: 2007-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Louis, MO, 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.