SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1— 510(k) K062140

Substantially Equivalent

Cryocath Technologies, Inc.

FDA 510(k) clearance K062140 for SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1, Substantially Equivalent on 2006-08-24. Applicant: Cryocath Technologies, Inc..

Clearance details

Applicant: Cryocath Technologies, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2006-07-27
Decision date: 2006-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Brookline, MA, 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.