CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680— 510(k) K964336

Substantially Equivalent

Cryomedical Sciences, Inc.

FDA 510(k) clearance K964336 for CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680, Substantially Equivalent on 1997-03-20. Applicant: Cryomedical Sciences, Inc..

Clearance details

Applicant: Cryomedical Sciences, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1996-10-31
Decision date: 1997-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.