GUIDE WIRE— 510(k) K813026

Substantially Equivalent

Inmed Corp.

FDA 510(k) clearance K813026 for GUIDE WIRE, Substantially Equivalent on 1981-11-17. Applicant: Inmed Corp..

Clearance details

Applicant: Inmed Corp.
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 1981-10-28
Decision date: 1981-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.