NOVOPEN SYSTEM (INSULIN SYRINGE)— 510(k) K861686

Name: FDA 510(k) clearance K861686
Creator: U.S. Food and Drug Administration
Published: 1987-01-21

Substantially Equivalent

Squibb-Novo, Inc.

FDA 510(k) clearance K861686 for NOVOPEN SYSTEM (INSULIN SYRINGE), Substantially Equivalent on 1987-01-21. Applicant: Squibb-Novo, Inc.. Device class: 2.

Clearance details

Applicant: Squibb-Novo, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1986-05-02
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.