DAUM NEUROBIOPSY NEEDLE— 510(k) K974631

Name: FDA 510(k) clearance K974631
Creator: U.S. Food and Drug Administration
Published: 1998-03-09

Substantially Equivalent

Daum Corp.

FDA 510(k) clearance K974631 for DAUM NEUROBIOPSY NEEDLE, Substantially Equivalent on 1998-03-09. 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: 1997-12-12
Decision date: 1998-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

view all

K260517 — Automatic Core Biopsy Instrument2026-08-28
K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K260572 — Marrow Marxman2026-08-04
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

More clearances from Daum Corp.

view all

K990278 — DAUM NEUROCUT NEUROBIOPSYNEEDLE1999-03-30
K981320 — DAUM BONE BIOPSY SET1998-06-29
K974574 — DAUM NEUROPUNCTURE NEEDLE1998-03-06
K974575 — DAUM ASPIRATIONBIOPSY NEEDLE1998-03-06
K974576 — DAUM BIOPSYGUN1998-03-06

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.