ULTIMED ULTICARE SAFETY SYRINGE— 510(k) K080600

Name: FDA 510(k) clearance K080600
Creator: U.S. Food and Drug Administration
Published: 2008-06-25

Substantially Equivalent

Ultimed, Inc.

FDA 510(k) clearance K080600 for ULTIMED ULTICARE SAFETY SYRINGE, Substantially Equivalent on 2008-06-25. Applicant: Ultimed, Inc.. Device class: 2.

Clearance details

Applicant: Ultimed, Inc.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2008-03-03
Decision date: 2008-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K062702 — ULTICARE DISPOSABLE SYRINGES AND NEEDLES2006-11-29
K050464 — ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/22005-05-11
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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.