LAURUS NEEDLE CORE BIOPSY SYSTEM— 510(k) K960317

Name: FDA 510(k) clearance K960317
Creator: U.S. Food and Drug Administration
Published: 1996-03-15

Substantially Equivalent

Laurus Medical Corp.

FDA 510(k) clearance K960317 for LAURUS NEEDLE CORE BIOPSY SYSTEM, Substantially Equivalent on 1996-03-15. Applicant: Laurus Medical Corp.. Device class: 2.

Clearance details

Applicant: Laurus Medical Corp.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1996-01-23
Decision date: 1996-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Laurus Medical Corp.

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K973415 — CURVILINEAR SUTURE PLACEMENT SYSTEM1997-12-02
K973215 — STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM1997-11-06
K932553 — DISPOSABLE SUTURE PLACEMENT SYSTEM1994-05-12

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.