Cry-Ac®, Cry-Ac-3®, Cry-Baby— 510(k) K193619

Substantially Equivalent

Brymill Cryogenic Systems

FDA 510(k) clearance K193619 for Cry-Ac®, Cry-Ac-3®, Cry-Baby, Substantially Equivalent on 2020-03-25. Applicant: Brymill Cryogenic Systems.

Clearance details

Applicant: Brymill Cryogenic Systems
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2019-12-26
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellington, CT, US

Download summary PDF View on FDA.gov ↗

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.