MILLEREISEN CURVED BIOPSY NEEDLE— 510(k) K840157

Name: FDA 510(k) clearance K840157
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Preventive Medicine Institute

FDA 510(k) clearance K840157 for MILLEREISEN CURVED BIOPSY NEEDLE, Substantially Equivalent on 1984-03-12. Applicant: Preventive Medicine Institute. Device class: 2.

Clearance details

Applicant: Preventive Medicine Institute
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-13
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K231422 — Precision GI2023-08-28
K231267 — ClearTip2023-06-30

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.