Verruca-Freeze H— 510(k) K243454

Substantially Equivalent

Cryosurgery, Inc.

FDA 510(k) clearance K243454 for Verruca-Freeze H, Substantially Equivalent on 2024-12-03. Applicant: Cryosurgery, Inc.. Device class: 2.

Clearance details

Applicant
Cryosurgery, Inc.
Product code
Code GEH
Device class
Class 2
Regulation
21 CFR 878.4350
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Nashville, TN, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.