CORAMATE/SPIROTOME SYSTEM— 510(k) K060384

Name: FDA 510(k) clearance K060384
Creator: U.S. Food and Drug Administration
Published: 2006-07-13

Substantially Equivalent

Medinvents

FDA 510(k) clearance K060384 for CORAMATE/SPIROTOME SYSTEM, Substantially Equivalent on 2006-07-13. Applicant: Medinvents. Device class: 2.

Clearance details

Applicant: Medinvents
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-14
Decision date: 2006-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasselt, Limburg, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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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 Medinvents

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K080095 — CORAMATE/SPIROTOME SYSTEM2008-04-11

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 →

Recalls naming K060384

K-number listed on FDA's recall record

Z-0124-2015 — Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.Class II·Terminated·Cook Medical Incorporated·20140926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060384.

Data sourced from openFDA. This site is unofficial and independent of the FDA.