FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05— 510(k) K061865

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K061865 for FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05, Substantially Equivalent on 2006-07-27. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2006-07-03
Decision date: 2006-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

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Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.