CRYOCARE CARDIAC SURGICAL SYSTEM— 510(k) K011040

Substantially Equivalent

Endocare, Inc.

FDA 510(k) clearance K011040 for CRYOCARE CARDIAC SURGICAL SYSTEM, Substantially Equivalent on 2001-06-15. Applicant: Endocare, Inc..

Clearance details

Applicant: Endocare, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2001-04-05
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.