CORAMATE/SPIROTOME SYSTEM— 510(k) K080095

Clearance details

Applicant

Medinvents

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2008-01-14

Decision date

2008-04-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hasselt, Limburg, BE

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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

• K060384 — CORAMATE/SPIROTOME SYSTEM2006-07-13

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 →

• 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 K080095.