CRYOSIL SILICONE GEL SHEETING— 510(k) K964047

Substantially Equivalent

Biodermis Corp.

FDA 510(k) clearance K964047 for CRYOSIL SILICONE GEL SHEETING, Substantially Equivalent on 1997-03-19. Applicant: Biodermis Corp..

Clearance details

Applicant: Biodermis Corp.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1996-10-09
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.