INTRABEAM NEEDLE APPLICATOR— 510(k) K110590

Name: FDA 510(k) clearance K110590
Creator: U.S. Food and Drug Administration
Published: 2012-04-13

Substantially Equivalent

Carl Zeiss Surgical GmbH

FDA 510(k) clearance K110590 for INTRABEAM NEEDLE APPLICATOR, Substantially Equivalent on 2012-04-13. Applicant: Carl Zeiss Surgical GmbH. Device class: 2.

Clearance details

Applicant: Carl Zeiss Surgical GmbH
Product code: Code JAD
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 2011-03-02
Decision date: 2012-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110590

K-number listed on FDA's recall record

Z-0001-2018 — Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatmentsClass II·Terminated·Carl Zeiss Meditec AG·20170830

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110590.

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