CASSI II Rotational Core Biopsy System— 510(k) K161234

Name: FDA 510(k) clearance K161234
Creator: U.S. Food and Drug Administration
Published: 2016-08-03

Substantially Equivalent

Scion Medical Technologies, LLC

FDA 510(k) clearance K161234 for CASSI II Rotational Core Biopsy System, Substantially Equivalent on 2016-08-03. Applicant: Scion Medical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Scion Medical Technologies, LLC
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-02
Decision date: 2016-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Newtown Square, PA, US

Download summary PDF View on FDA.gov ↗

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K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
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K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

More clearances from Scion Medical Technologies, LLC

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K170905 — Star Tissue Marker2017-04-27
K153189 — Beacon Tissue Marker (SE)2015-12-17
K140835 — GENERAL AND PLASTIC SURGERY2014-05-20
K130763 — BEACON TISSUE MARKER2013-05-08
K123606 — CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE2013-03-01

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.