INTRACAVITY NEEDLE GUIDE KIT— 510(k) K955668

Name: FDA 510(k) clearance K955668
Creator: U.S. Food and Drug Administration
Published: 1997-07-30

Substantially Equivalent

Arlanda Medicinska Instrument Co. AB

FDA 510(k) clearance K955668 for INTRACAVITY NEEDLE GUIDE KIT, Substantially Equivalent on 1997-07-30. Applicant: Arlanda Medicinska Instrument Co. AB. Device class: 2.

Clearance details

Applicant: Arlanda Medicinska Instrument Co. AB
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 1995-12-13
Decision date: 1997-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 191 47 Sollentuna, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.