SNM FIRMGRIP— 510(k) K092629

Substantially Equivalent

Flexicath , Ltd.

FDA 510(k) clearance K092629 for SNM FIRMGRIP, Substantially Equivalent on 2009-09-25. Applicant: Flexicath , Ltd..

Clearance details

Applicant: Flexicath , Ltd.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2009-08-27
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.