RADI-BIOPSY DEVICE— 510(k) K850605

Name: FDA 510(k) clearance K850605
Creator: U.S. Food and Drug Administration
Published: 1985-08-09

Substantially Equivalent

Radiplast AB

FDA 510(k) clearance K850605 for RADI-BIOPSY DEVICE, Substantially Equivalent on 1985-08-09. Applicant: Radiplast AB. Device class: 2.

Clearance details

Applicant: Radiplast AB
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-15
Decision date: 1985-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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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

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.