ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM— 510(k) K963970

Substantially Equivalent

Endocare, Inc.

FDA 510(k) clearance K963970 for ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM, Substantially Equivalent on 1997-02-25. Applicant: Endocare, Inc..

Clearance details

Applicant: Endocare, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1996-10-03
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.