CryoThin Surgical System and Accessories— 510(k) K231661

Substantially Equivalent

Medinux (Tianjin) Technologies Co., Ltd.

FDA 510(k) clearance K231661 for CryoThin Surgical System and Accessories, Substantially Equivalent on 2023-11-27. Applicant: Medinux (Tianjin) Technologies Co., Ltd..

Clearance details

Applicant: Medinux (Tianjin) Technologies Co., Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2023-06-07
Decision date: 2023-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

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.