CRYOPROBES MC-1400-CRYOSURG-CONSOLE— 510(k) K832385

Substantially Equivalent

Spembly Medical , Ltd.

FDA 510(k) clearance K832385 for CRYOPROBES MC-1400-CRYOSURG-CONSOLE, Substantially Equivalent on 1983-09-12. Applicant: Spembly Medical , Ltd..

Clearance details

Applicant: Spembly Medical , Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1983-07-19
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.