DAUM BONE BIOPSY SET— 510(k) K981320

Name: FDA 510(k) clearance K981320
Creator: U.S. Food and Drug Administration
Published: 1998-06-29

Substantially Equivalent

Daum Corp.

FDA 510(k) clearance K981320 for DAUM BONE BIOPSY SET, Substantially Equivalent on 1998-06-29. Applicant: Daum Corp.. Device class: 2.

Clearance details

Applicant: Daum Corp.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1998-04-10
Decision date: 1998-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

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K974575 — DAUM ASPIRATIONBIOPSY NEEDLE1998-03-06
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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.