PORT-O-SCOPE(TM)— 510(k) K895948

Name: FDA 510(k) clearance K895948
Creator: U.S. Food and Drug Administration
Published: 1990-03-27

Substantially Equivalent

North American Medical Products, Inc.

FDA 510(k) clearance K895948 for PORT-O-SCOPE(TM), Substantially Equivalent on 1990-03-27. Applicant: North American Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: North American Medical Products, Inc.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1989-10-10
Decision date: 1990-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loudonville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.