RNS STERILE, DISPOSABLE CT BIOPSY TRAY— 510(k) K955685

Substantially Equivalent

Contour Fabricators of Florida, Inc.

FDA 510(k) clearance K955685 for RNS STERILE, DISPOSABLE CT BIOPSY TRAY, Substantially Equivalent on 1996-10-04. Applicant: Contour Fabricators of Florida, Inc..

Clearance details

Applicant: Contour Fabricators of Florida, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1995-12-14
Decision date: 1996-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harobor, FL, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.