ExpressCore Biopsy Device— 510(k) K243886

Name: FDA 510(k) clearance K243886
Creator: U.S. Food and Drug Administration
Published: 2025-04-29

Substantially Equivalent

Inrad, Inc.

FDA 510(k) clearance K243886 for ExpressCore Biopsy Device, Substantially Equivalent on 2025-04-29. Applicant: Inrad, Inc.. Device class: 2.

Clearance details

Applicant: Inrad, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-18
Decision date: 2025-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kentwood, MI, US

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

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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.