FLEX FINDER GUIDEWIRE— 510(k) K923755

Substantially Equivalent

Flex Medics Corporation

FDA 510(k) clearance K923755 for FLEX FINDER GUIDEWIRE, Substantially Equivalent on 1993-09-03. Applicant: Flex Medics Corporation.

Clearance details

Applicant: Flex Medics Corporation
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 1992-07-24
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.