SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE— 510(k) K053436

Substantially Equivalent

Cryocath Technologies, Inc.

FDA 510(k) clearance K053436 for SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE, Substantially Equivalent on 2006-01-13. Applicant: Cryocath Technologies, Inc..

Clearance details

Applicant: Cryocath Technologies, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2005-12-09
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Brookline, MA, US

Download summary PDF View on FDA.gov ↗

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.