QUICK-CUT AUTOMATIC BIOPSY SYSTEM— 510(k) K980479

Name: FDA 510(k) clearance K980479
Creator: U.S. Food and Drug Administration
Published: 1998-05-06

Substantially Equivalent

Gallini U.S., LLC

FDA 510(k) clearance K980479 for QUICK-CUT AUTOMATIC BIOPSY SYSTEM, Substantially Equivalent on 1998-05-06. Applicant: Gallini U.S., LLC. Device class: 2.

Clearance details

Applicant: Gallini U.S., LLC
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-06
Decision date: 1998-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gallini U.S., LLC

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K992499 — GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE1999-08-12
K990645 — GALLINI ATRA-CUT NEEDLE1999-05-19
K990716 — GALLINI BYCUT NEEDLE1999-05-17
K981301 — SPEED-CUT AUTOMATIC BIOPSY SYSTEM1998-07-08
K980676 — SPIGAL NEEDLE1998-05-21

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.