SECURE-SITE— 510(k) K941098

Substantially Equivalent

Op-Co Medical Products , Ltd.

FDA 510(k) clearance K941098 for SECURE-SITE, Substantially Equivalent on 1995-08-09. Applicant: Op-Co Medical Products , Ltd..

Clearance details

Applicant: Op-Co Medical Products , Ltd.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1994-03-09
Decision date: 1995-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York City, NY, US

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.