Semi-automatic Biopsy-Needle (9 models)— 510(k) K222462

Name: FDA 510(k) clearance K222462
Creator: U.S. Food and Drug Administration
Published: 2023-01-20

Substantially Equivalent

Itp Innovative Tomography Products GmbH

FDA 510(k) clearance K222462 for Semi-automatic Biopsy-Needle (9 models), Substantially Equivalent on 2023-01-20. Applicant: Itp Innovative Tomography Products GmbH. Device class: 2.

Clearance details

Device name as filed: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
Applicant: Itp Innovative Tomography Products GmbH
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-15
Decision date: 2023-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bochum, DE

Download summary PDF View on FDA.gov ↗

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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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K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM2024-06-18

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.