THE BIOPSY TOOL— 510(k) K941563

Name: FDA 510(k) clearance K941563
Creator: U.S. Food and Drug Administration
Published: 1994-09-26

Substantially Equivalent

Citation Medical Corp.

FDA 510(k) clearance K941563 for THE BIOPSY TOOL, Substantially Equivalent on 1994-09-26. Applicant: Citation Medical Corp.. Device class: 2.

Clearance details

Applicant: Citation Medical Corp.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-01
Decision date: 1994-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

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K945390 — CITATION DELTA SCOPE1995-06-23
K946290 — CITATION POWER TOOL1995-06-15
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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.