FLEX-IV— 510(k) K911251

Substantially Equivalent

Medway

FDA 510(k) clearance K911251 for FLEX-IV, Substantially Equivalent on 1991-10-28. Applicant: Medway.

Clearance details

Applicant: Medway
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1991-03-21
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, TN, US

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.