HIGH SPEED CORE CUT BIOPSY GUN— 510(k) K905556

Name: FDA 510(k) clearance K905556
Creator: U.S. Food and Drug Administration
Published: 1991-03-08

Substantially Equivalent

Uni-Quatro Industries Canada, Inc.

FDA 510(k) clearance K905556 for HIGH SPEED CORE CUT BIOPSY GUN, Substantially Equivalent on 1991-03-08. Applicant: Uni-Quatro Industries Canada, Inc.. Device class: 2.

Clearance details

Applicant: Uni-Quatro Industries Canada, Inc.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-11
Decision date: 1991-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niagara Falls, Ontario, CA

Download summary PDF View on FDA.gov ↗

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K915801 — BIP-COAX-SYSTEM1994-03-11
K905557 — CCC CROWN-CORE-CUT-NEEDLE1991-03-08

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.