CRYO-MONO CRYOGRNIC SYSTEM— 510(k) K991122

Substantially Equivalent

Influence, Inc.

FDA 510(k) clearance K991122 for CRYO-MONO CRYOGRNIC SYSTEM, Substantially Equivalent on 1999-07-01. Applicant: Influence, Inc..

Clearance details

Applicant: Influence, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1999-04-02
Decision date: 1999-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, 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.