SYRINGE NEEDLE INTRODUCER— 510(k) K901803

Name: FDA 510(k) clearance K901803
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Glaxo, Inc.

FDA 510(k) clearance K901803 for SYRINGE NEEDLE INTRODUCER, Substantially Equivalent on 1990-11-20. Applicant: Glaxo, Inc.. Device class: 2.

Clearance details

Applicant: Glaxo, Inc.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1990-04-19
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.